End Stage Renal DiseasePhase 2NCT01147666

Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

A Phase 2 study testing Roxadustat and Epoetin Alfa in people with End Stage Renal Disease and Anemia, run by Kyntra Bio at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: End Stage Renal Disease, Anemia
What is being tested?: Roxadustat and Epoetin Alfa
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 161 participants
Where: 25 sitesUnited States
Study dates: 17 May 2010to 15 Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ESRD and receiving maintenance HD TIW for ≥4 months prior to Day 1
Two most recent Hb values obtained during screening period must be within the ranges set below:
Group A. Normoresponder Criteria: Hb range in the 8 weeks prior to randomization within 9.0 to 13.5 g/dL ii) Group B. Hyporesponder Criteria: Hb range in the 8 weeks prior to randomization within 8.5 to 13.5 g/dL
Epoetin alfa, dose requirements:
Group A. Normoresponder Criteria - Cohorts A-1 to A-12: Stable IV epoetin alfa dose at baseline (that is, no more than a 30% fluctuation in the weekly dose) during the 4 weeks prior to study Day -3
Cohorts A-1 to A-4: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 85 IU/kg/dose, TIW; weekly dose between 75 and 255 IU/kg/week

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Cohort A-5: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 115 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
Cohort A-9: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 150 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
Cohorts A-6 to A-8: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 115 IU/kg/dose, TIW, and two times a week (BIW); total weekly dose between 75 and 345 IU/kg/week
Cohorts A-10 to A-12: Optional cohorts to be decided (TBD), dosing frequency and dose range to be determined by sponsor ii) Group B. Hyporesponder Criteria:
Cohort B-1 (completed): Current and previous (past 4 weeks) epoetin alfa dose range 125 to 400 IU/kg/dose, TIW; weekly dose between 375 and 1200 IU/kg/week
Cohort B-2 to B-4: Current and previous (past 4 weeks) epoetin alfa dose range >115 IU/kg/dose, TIW; total weekly dose >345 IU/kg/week no requirement for stability of epoetin alfa doses
Complete Blood Count (CBC), Hematology, liver function blood tests, serum folate and vitamin B12 within acceptable limits
Absence of active or chronic gastrointestinal bleeding
High sensitivity C-reactive protein (hsCRP) <60 mg/liter for normoresponders Cohorts A-8 through A-12 enrolled under Amendment 3; no hsCRP criteria for hyporesponders
Body weight: 40 to 140 kg (dry weight)
Body mass index (BMI): 18 to 45 kg/meter square (m^2)
Dialysis vascular access via native arteriovenous fistula or synthetic graft, or permanent (tunneled) catheter (not via temporary catheter); permanent and temporary catheters, however, are still prohibited in Cohort A-5

Who cannot join

Anticipated change in HD prescription
Any clinically significant infection or evidence of an underlying infection
Positive for any of the following: Human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission

Show all 18Show fewer

History of myelodysplastic syndrome
History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism
Any prior organ transplantation
Drug-treated gastroparesis or short-bowel syndrome
History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the participant
Prior treatment with roxadustat
Diagnosis or suspicion of renal cell carcinoma
Red blood cell (RBC) transfusion within 12 weeks prior to Day 1, or anticipated need for RBC transfusion during the dosing period
IV iron supplement within 2 weeks prior to Day 1 and/or unwilling to withhold IV iron during the dosing/treatment period

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Arlington, Texas
Study site
Azusa, California
Study site
Detroit, Michigan
Study site
Fairfax, Virginia
Study site
Fort Worth, Texas
Study site
Honolulu, Hawaii
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Miami, Florida
Study site
New York, New York
Study site
Northridge, California
Study site
Ontario, California
Study site
Orangeburg, South Carolina
Study site
Paramount, California
Study site
Paterson, New Jersey
Study site
Pembroke Pines, Florida
Study site
Pine Bluff, Arkansas
Study site
Rosedale, New York
Study site
San Antonio, Texas
Study site
Tempe, Arizona
Study site
Toledo, Ohio
Study site
Williamsville, New York
Study site
Yuba City, California

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis

Read the detailed description

Dose ranging study with consecutive cohorts in two participant populations: participants normally responding to current anemia treatment (epoetin alfa) ("normoresponders": participants with baseline epoetin alfa dose at study entry 75 to 450 international units [IU]/kilograms [kg]/week) and participants not responding well to current treatment ("hyporesponders": participants with maintenance epoetin alfa dose above 450 IU/kg/week). Normoresponders are randomized to study drug roxadustat or epoetin alfa at a ratio of 3:1; hyporesponders are randomized to study drug roxadustat or epoetin alfa or placebo at a ratio of 2:1:1. The study objectives are to demonstrate that roxadustat is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.

Conditions: End Stage Renal Disease, Anemia
Being tested: Roxadustat, Epoetin Alfa, Placebo
Keywords: Kidney, End Stage Renal Disease, ESRD, Chronic Kidney Disease, CKD, Renal, Anemia, Oral anemia treatment, Hemoglobin levels, Blood count, Erythropoietin, Hemodialysis, Normoresponder, Hyporesponder
Medical subject headings: Kidney Failure, Chronic, Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RoxadustatDrug
Also called FG-4592
Roxadustat will be administered per dose and schedule specified in the arms.
Epoetin AlfaDrug
Epoetin Alfa will be administered per dose and schedule specified in the arms.
PlaceboOther
Placebo matching to roxadustat will be administered per schedule specified in the arm.

Study groups in NCT01147666
Study group	Role	What they receive
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 grams [g]/deciliter [dL]) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-9 (Roxadustat 2.0 mg/kg)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)	Experimental	Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohorts A (Epoetin Alfa)	Active comparator	Normoresponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort A. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants. Receives: Drug: Epoetin Alfa
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)	Experimental	Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)	Experimental	Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb. Receives: Drug: Roxadustat
Cohort B (Epoetin Alfa)	Active comparator	Hyporesponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort B. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants. Receives: Drug: Epoetin Alfa
Cohort B (Placebo)	Placebo comparator	Hyporesponsive participants will receive placebo matched to roxadustat, administered orally TIW for 19 weeks. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Measured: Week 7
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Measured: Week 7
Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Measured: Weeks 17, 18, 19, and 20

Secondary outcomes (16)

Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Measured: Weeks 17, 18, 19, and 20
Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values.
Measured: Weeks 17, 18, 19, and 20
Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Measured: Baseline, Week 7
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Measured: Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Measured: Baseline up to Week 6
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Measured: Baseline up to Week 19
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
Measured: Week 7
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
Measured: Week 7
Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Measured: Week 7
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Measured: Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Measured: Baseline up to Week 6
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Measured: Baseline up to Week 19
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
Measured: Baseline up to Week 6
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
Measured: Baseline up to Week 19
Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Measured: Baseline up to Week 6
Trough Plasma Concentration of Roxadustat and Epoetin Alfa
Measured: Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201015 Oct 2012

First posted22 Jun 2010 (estimated)
Study start17 May 2010
Primary completion15 Oct 2012
Study completion15 Oct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01147666
Sponsor's protocol ID: FGCL-4592-040
Status last verified: Dec 2021
First submitted: 20 May 2010
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis
ClinicalTrials.gov ID: NCT01147666
Acronym / sponsor ID: FGCL-4592-040
Conditions: End Stage Renal Disease, Anemia
Keywords: Kidney, End Stage Renal Disease, ESRD, Chronic Kidney Disease, CKD, Renal, Anemia, Oral anemia treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Kyntra BioIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca, Astellas Pharma Inc
Study start: 17 May 2010 (actual)
Primary completion: 15 Oct 2012 (actual)
Study completion: 15 Oct 2012 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 11 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 15

Arm	Type	Receives
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 grams [g]/deciliter [dL]) will be based upon regular monitoring of Hb.
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-9 (Roxadustat 2.0 mg/kg)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)	Experimental	Drug: RoxadustatNormoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohorts A (Epoetin Alfa)	Active comparator	Drug: Epoetin AlfaNormoresponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort A. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)	Experimental	Drug: RoxadustatHyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)	Experimental	Drug: RoxadustatHyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Cohort B (Epoetin Alfa)	Active comparator	Drug: Epoetin AlfaHyporesponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort B. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Cohort B (Placebo)	Placebo comparator	Other: PlaceboHyporesponsive participants will receive placebo matched to roxadustat, administered orally TIW for 19 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

ESRD and receiving maintenance HD TIW for ≥4 months prior to Day 1
Two most recent Hb values obtained during screening period must be within the ranges set below:
Epoetin alfa, dose requirements:
Complete Blood Count (CBC), Hematology, liver function blood tests, serum folate and vitamin B12 within acceptable limits

Key exclusion criteria (18 listed)

Anticipated change in HD prescription
Any clinically significant infection or evidence of an underlying infection
Positive for any of the following: Human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RoxadustatAlso: FG-4592Roxadustat will be administered per dose and schedule specified in the arms.	Drug	Cohort A-1 (Roxadustat 1.0 mg/kg TIW), Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg), Cohort A-2 (Roxadustat 1.5 mg/kg TIW), Cohort A-3 (Roxadustat 2.0 mg/kg TIW), Cohort A-4 (Roxadustat 1.8 mg/kg TIW), Cohort A-5 (Roxadustat 1.8 mg/kg TIW), Cohort A-6 (Roxadustat 1.3 mg/kg TIW), Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg), Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg), Cohort A-9 (Roxadustat 2.0 mg/kg), Cohort B-1 (Roxadustat 1.5 mg/kg TIW), Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Epoetin AlfaEpoetin Alfa will be administered per dose and schedule specified in the arms.	Drug	Cohort B (Epoetin Alfa), Cohorts A (Epoetin Alfa)
PlaceboPlacebo matching to roxadustat will be administered per schedule specified in the arm.	Other	Cohort B (Placebo)

Primary outcome

Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
Time frame: Week 7
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
Time frame: Week 7
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
Time frame: Weeks 17, 18, 19, and 20
The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.

16 secondary outcomes

Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
Time frame: Weeks 17, 18, 19, and 20
Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
Time frame: Weeks 17, 18, 19, and 20
Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
Time frame: Baseline, Week 7
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Time frame: Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Time frame: Baseline up to Week 6
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Time frame: Baseline up to Week 19
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
Time frame: Week 7
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
Time frame: Week 7
Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
Time frame: Week 7
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Time frame: Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
Time frame: Baseline up to Week 6
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
Time frame: Baseline up to Week 19
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
Time frame: Baseline up to Week 6
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
Time frame: Baseline up to Week 19
Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
Time frame: Baseline up to Week 6
Trough Plasma Concentration of Roxadustat and Epoetin Alfa
Time frame: Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)	12	10
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)	12	10
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)	12	11
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)	12	10
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)	12	7
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)	12	9
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)	12	9
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)	12	9
Cohort A-9 (Roxadustat 2.0 mg/kg)	2	2
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)	10	8
Cohorts A (Epoetin Alfa)	36	33
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)	4	2
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)	5	1
Cohort B (Epoetin Alfa)	4	3
Cohort B (Placebo)	4	0

Primary outcome: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only

Time frame: Week 7. Count of participants. Unit: Participants

Measure	Cohort A-1 (Roxadustat 1.0 mg/kg TIW) n = 9	Cohort A-2 (Roxadustat 1.5 mg/kg TIW) n = 10	Cohort A-3 (Roxadustat 2.0 mg/kg TIW) n = 9	Cohort A-4 (Roxadustat 1.8 mg/kg TIW) n = 5	Cohort A (Epoetin Alfa) n = 9
Value	4	8	7	4	3

Cohort A-1 (Roxadustat 1.0 mg/kg TIW) vs Cohort A (Epoetin Alfa): p = 1.0000, Fisher Exact
Cohort A-2 (Roxadustat 1.5 mg/kg TIW) vs Cohort A (Epoetin Alfa): p = 0.0698, Fisher Exact
Cohort A-3 (Roxadustat 2.0 mg/kg TIW) vs Cohort A (Epoetin Alfa): p = 0.1534, Fisher Exact

Population analysed: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (erythropoiesis-stimulating agent \[ESA\], IV Iron or red blood cell \[RBC\] transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies normoresponder participants who were treated for 6 weeks only.

Primary outcome: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks

Time frame: Week 7. Count of participants. Unit: Participants

Measure	Cohort B-1 (Roxadustat 1.5 mg/kg TIW) n = 1	Cohort B-2 (Roxadustat 2.0 mg/kg TIW) n = 3	Cohort B (Epoetin Alfa) n = 4	Cohort B (Placebo) n = 3
Value	0	1	2	0

Cohort B-2 (Roxadustat 2.0 mg/kg TIW) vs Cohort B (Placebo): p = 1.0000, Fisher Exact

Population analysed: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.

Primary outcome: Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks

Time frame: Weeks 17, 18, 19, and 20. Count of participants. Unit: Participants

Measure	Cohort A-4 (Roxadustat 1.8 mg/kg TIW) n = 6	Cohort A-5 (Roxadustat 1.8 mg/kg TIW) n = 11	Cohort A-6 (Roxadustat 1.3 mg/kg TIW) n = 11	Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) n = 11	Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) n = 10	Cohort A-9 (Roxadustat 2.0 mg/kg) n = 2	Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) n = 10	Cohorts A (Epoetin Alfa) n = 22	Cohort B-2 (Roxadustat 2.0 mg/kg TIW) n = 3	Cohort B (Epoetin Alfa) n = 3	Cohort B (Placebo) n = 2
Value	4	4	6	5	6	2	4	8	0	0	0

Population analysed: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 23. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)	0 of 12 (0%)	3 of 12 (25%)	Not reported
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)	3 of 12 (25%)	1 of 12 (8.3%)	Not reported
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)	4 of 12 (33.3%)	4 of 12 (33.3%)	Not reported
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)	5 of 12 (41.7%)	2 of 12 (16.7%)	Not reported
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)	3 of 12 (25%)	2 of 12 (16.7%)	Not reported
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)	5 of 12 (41.7%)	1 of 12 (8.3%)	Not reported
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)	3 of 12 (25%)	2 of 12 (16.7%)	Not reported
Cohort A-9 (Roxadustat 2.0 mg/kg)	0 of 2 (0%)	0 of 2 (0%)	Not reported
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)	3 of 10 (30%)	3 of 10 (30%)	Not reported
Cohorts A (Epoetin Alfa)	6 of 36 (16.7%)	2 of 36 (5.6%)	Not reported
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)	2 of 4 (50%)	3 of 4 (75%)	Not reported
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)	2 of 5 (40%)	2 of 5 (40%)	Not reported
Cohort B (Epoetin Alfa)	1 of 4 (25%)	0 of 4 (0%)	Not reported
Cohort B (Placebo)	0 of 4 (0%)	1 of 4 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marietta Franco study director

Kyntra Bio

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roxadustat and Epoetin Alfa in people with End Stage Renal Disease and Anemia, run by Kyntra Bio at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only (time frame: Week 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01147666, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.