AzTrials
AzTrials

Anemia in Incident Dialysis PatientsPhase 3HimalayasNCT02052310

Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

A Phase 3 study testing Roxadustat and Epoetin Alfa in people with Anemia in Incident Dialysis Patients, run by Kyntra Bio at 113 sites in 15 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia in Incident Dialysis Patients
What is being tested?
Roxadustat and Epoetin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,043 participants
Where
113 sitesin 15 countries
Study dates
11 Feb 2014to 21 Sep 2018
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
  • Receiving HD or PD for ESRD for a minimum of 2 weeks and a maximum of 4 months, prior to randomization.
  • Hemodialysis access consisting of an arteriovenous (AV) fistula, AV graft, or tunnelled (permanent) catheter; or PD catheter in use.
  • Mean of the two most recent predialysis Hb values during the Screening Period, obtained at least 2 days apart, must be ≤ 10.0 g/dL, with a difference of ≤ 1.3 g/dL between the highest and the lowest values. The last Hb value must be drawn within 10 days prior to randomization.
  • Ferritin ≥ 100 nanograms (ng)/milliliter (mL) (≥ 220 picomoles (pmol)/L); participants with ferritin level < 100 ng/mL(<220 pmol/L) during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest ferritin prior to randomization.
  • Transferrin saturation ≥ 20%; participants with TSAT level < 20% during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest TSAT prior to randomization.
Show all 10Show fewer
  • Serum folate level, performed within 8 weeks prior to randomization ≥ lower limit of normal (LLN); participants with serum folate level < LLN during screening, qualify after receiving folate supplement (per local standard of care), without the need to retest folate prior to randomization.
  • Serum vitamin B12 level, performed within 8 weeks prior to randomization ≥ LLN; participants with vitamin B12 level < LLN during screening, qualify after receiving B12 supplement (per local standard of care), without the need to retest B12 prior to randomization.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 * upper limit of normal (ULN), and total bilirubin ≤ 1.5 * ULN.
  • Body weight up to 160 kg (HD participants: dry weight).

Who cannot join

  • Total duration of prior effective ESA use must be ≤3 weeks within the preceding 12 weeks at the time informed consent is obtained.
  • Specific dosing guidance, depending on the type of ESAs, injected IV or SC within 12 weeks prior to start of screening are as follows:
  • Short-acting ESAs (EPO-alfa or equivalents) - IV: Up to 9 doses, last EPO dose must be ≥2 days prior to start of screening; SC: Up to 3 doses, last EPO dose must be ≥1 week (7 days) prior to start of screening ii) Darbepoetin - IV: Up to 3 doses, last darbepoetin dose must be ≥1 week (7 days) prior to start of screening; SC: Up to 2 doses, last darbepoetin dose must be ≥2 weeks (14 days) prior to start of screening iii) Continuous erythropoietin receptor activator (CERA) IV and SC: Up to 2 doses; last CERA dose must be ≥2 weeks (14 days) prior to start of screening
  • Intravenous iron: there is no restriction regarding IV iron use during screening, provided it is administered in accordance with local SOC.
  • Red blood cell transfusion within 4 weeks prior to randomization.
  • Active, clinically significant infection that could be manifested by white blood cell (WBC) count > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection at the time of randomization.
Show all 33Show fewer
  • History of chronic liver disease (for example, chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver).
  • New York Heart Association Class III or IV congestive heart failure at screening.
  • Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event within a major vessel (excluding vascular dialysis access) (for example, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
  • Uncontrolled hypertension, in the opinion of the Investigator, (for example, that requires a change in anti-hypertensive medication) within 2 weeks prior to randomization.
  • Renal imaging performed within 12 weeks prior to randomization indicative of a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category 2 or higher) of renal cell carcinoma.
  • History of malignancy, except for the following: cancers determined to be cured or in remission for ≥ 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
  • Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).
  • Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
  • Known, untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration, or retinal vein occlusion (participants who are already blind for the above reasons qualify to participate).
  • Known history of myelodysplastic syndrome or multiple myeloma.
  • Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than chronic kidney disease (CKD).
  • Known hemosiderosis, hemochromatosis, coagulation disorder, or a hypercoagulable condition.
  • Organ transplant: participants with any of the following:
  • Experienced rejection of a transplanted organ within 6 months of transplantation
  • Currently on high doses of immunosuppressive therapy (per discretion of the Investigator)
  • Scheduled for organ transplantation. Note: being on a waiting list for kidney transplant is not exclusionary
  • Anticipated elective surgery, except for vascular access surgery or dialysis catheter placement, that is expected to lead to significant blood loss, or anticipated elective coronary revascularization.
  • Active or chronic gastrointestinal bleeding.
  • Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
  • Use of iron-chelating agents within 4 weeks prior to randomization.
  • Known hypersensitivity reaction to any ESA.
  • Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to randomization.
  • Anticipated use of dapsone or androgens at any dose amount or chronic use of acetaminophen or paracetamol > 2.0 g/day during the study.
  • History of alcohol or drug abuse within 6 months prior to randomization.
  • Females of childbearing potential, unless using contraception as detailed in the protocol; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use contraception.
  • Pregnant or breastfeeding females.
  • Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this study, may confound efficacy or safety assessment, or may interfere with study participation.

Trial locations and contacts

113 sites in 15 countries.

113 sites in 15 countries

United States30 sites

  • Investigational Site

    Albuquerque, New Mexico, 87109

  • Investigational Site

    Brookhaven, Mississippi, 39601

  • Investigational Site

    Chula Vista, California, 91910

  • Investigational Site

    Columbia, South Carolina, 29203

  • Investigational Site

    Columbus, Mississippi, 39705

  • Investigational Site

    Columbus, Ohio, 43215

  • Investigational Site

    Coral Springs, Florida, 33071

  • Investigational Site

    Detroit, Michigan, 48236

  • Investigational Site

    Durham, North Carolina, 27704

  • Investigational Site

    Edinburg, Texas, 78539

  • Investigational Site

    Gulfport, Mississippi, 39501

  • Investigational Site

    Houston, Texas, 77099

  • Investigational Site

    Houston, Texas, 77450

  • Investigational Site

    Knoxville, Tennessee, 37923

  • Investigational Site

    La Mesa, California, 91942

  • Investigational Site

    Lauderdale Lakes, Florida, 33313-1638

  • Meridian

    Meridian, Idaho, 83642

  • Investigational Site

    Miami, Florida, 33143

  • Investigational Site

    Miami, Florida, 33173

  • Investigational Site

    New Bern, North Carolina, 28562

  • Investigational Site

    Orangeburg, South Carolina, 29118

  • Investigational Site

    Pontiac, Michigan, 48341

  • Investigational Site

    Portsmouth, New Hampshire, 38815

  • Investigational Site

    Saint Ann, Missouri, 63074

  • Investigational Site

    San Diego, California, 92111

  • Investigational Site

    Shreveport, Louisiana, 71101

  • Investigational Site

    St Louis, Missouri, 63136

  • Investigational Site

    Sumter, South Carolina, 29150

  • Investigational Site

    Tampa, Florida, 33614

  • Investigational Site

    Tupelo, Mississippi, 38801

Other trials in United States

Russia21 sites

  • Investigational Site

    Kaluga, Russian Federation, 248007

  • Investigational Site

    Kolomna, 140407

  • Investigational Site

    Krasnodar, Russian Federation, 350051

  • Investigational Site

    Krasnodar, 350029

  • Investigational Site

    Moscow, Russian Federation, 115446

  • Investigational Site

    Moscow, Russian Ferderation, 125284

  • investigational Site

    Moscow, 129327

  • Investigational Site

    Nizhny Novgorod, Russian Federation, 603076

  • Investigational Site

    Novorossiysk, 353915

  • Investigational site

    Omsk, 644112

  • Investigational Site

    Orenburg, 460040

  • Investigational Site

    Petrozavodsk, Russian Federation, 185019

  • Investigational Site

    Rostov-on-Don, 142100

  • Investigational Site

    Saint Petersburg, Russian Federation, 191104

  • Investigational Site

    Saint Petersburg, Russian Federation, 192242

  • Investigational Site

    Saint Petersburg, Russian Federation, 193318

  • Investigational Site

    Saint Petersburg, Russian Federation, 195257

  • Investigational Site

    Saint Petersburg, 194354

  • Investigational site

    Saint Petersburg, 196247

  • Investigational Site

    Saint Petersburg, 197110

  • Investigational Site

    Smolensk, Russian Federation, 214006

Other trials in Russia

Bulgaria13 sites

  • Investigational Site

    Burgas, 8000

  • Investigational site

    Dobrich, 9300

  • Investigational site

    Pazardzhik, 4400

  • Investigational site

    Pernik, 2300

  • Investigational Site

    Pleven, 5800

  • Investigational Site

    Plovdiv, 4003

  • Investigational site

    Rousse, 7000

  • Investigational Site

    Sofia, 1233

  • Investigational Site

    Sofia, 1407

  • Investigational site

    Sofia, 1431

  • Investigational Site

    Sofia, 1504

  • Invesigational Site

    Stara Zagora, 6000

  • Investigational Site

    Varna, 9000

Other trials in Bulgaria

Romania8 sites

  • Investigational Site

    Bucharest, District 3, 031422

  • Investigational Site

    Bucharest, 020475

  • Investigational Site

    Bucharest, 022305

  • Investigational Site

    Bucharest, 022325

  • Investigational Site

    Bucharest, 022329

  • Investigational Site

    Craiova, 200349

  • Investigational Site

    Slatina, 230108

  • Investigational Site

    Târgu Mureş, 540098

Other trials in Romania

Ukraine7 sites

  • Investigational Site

    Ivano, Frankivisk, 76008

  • Investigational Site

    Karkiev, 61037

  • Investigational Site

    Kiev, 02125

  • Investigational Site

    Mykolayiv, 54058

  • Investigational Site

    Ternopil, 46002

  • Investigational Site

    Zaporizhzhya, 69118

  • Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Malaysia6 sites

  • Investigational Site

    Alor Star, 05460

  • Investigational Site

    George Town, 10990

  • Investigational Site

    Kuala Lumpur, 43000

  • Investigational Site

    Kuala Lumpur, 50586

  • Investigational Site

    Miri, Sarawak, 98000

  • Investigational Site

    Taiping, 34000

Other trials in Malaysia

South Korea6 sites

  • Investigational Site

    Anyang-si, 431-796

  • Investigational site

    Goyang-si, Gyeonggi-do, 410-719

  • Investigational Site

    Guri-si, Gyeonggi-do, 471-701

  • Investigational Site

    Seongnam-si, Gyeonggi-do, 463-712

  • Investigational Site

    Seoul, 130-872

  • Investigational Site

    Seoul, 134-727

Other trials in South Korea

Poland5 sites

  • Investigational Site

    Chorzów, 41-500

  • Investigational Site

    Golub-Dobrzyń, 87-400

  • Investigational Site

    Inowrocław, 88-100

  • Investigational Site

    Katowice, 40-027

  • Investigational Drug

    Pruszków, 05-804

Other trials in Poland

Taiwan4 sites

  • Investigational Site

    Kaohsiung City, 83301

  • Investigational Site,

    New Taipei City, 235

  • Investigational Site

    Taichung, 40447

  • Investigational Site

    Taichung, 433

Other trials in Taiwan

Latvia3 sites

  • Investigational Site

    Riga, LV-1038

  • Invetigational Site

    Riga, LV1001

  • Investigational Site

    Ventspils, LV3601

Other trials in Latvia

Argentina2 sites

  • Investigational Site

    Santa Fe, IX Region, S3000EPU

  • Investigational Site

    Serandi, Buenos Aires, 1872

Other trials in Argentina

Chile2 sites

  • Investigational Site

    La Serena, Coquimbo Region, 1720421

  • Investigational Site

    Temuco, Araucania, 4781151

Other trials in Chile

Colombia2 sites

  • Investigational Site

    Barranquilla, Atlántico

  • Investigational Site

    Barranquilla

Other trials in Colombia

Mexico2 sites

  • Investigational Site

    Aguascalientes, 20230

  • Investigational Site

    San Luis Potosí City, 78240

Other trials in Mexico

Thailand2 sites

  • Investigational Site

    Bangkok, 10330

  • Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.

Read the detailed description

There is a screening period of up to 6 weeks, a treatment period of a minimum of 52 weeks and a maximum of approximately up to 3 years after last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants will be randomized in a 1:1 ratio to receive either open-label roxadustat or epoetin alfa (active control).

Being tested
Roxadustat, Epoetin Alfa
Keywords
Anemia, Chronic Kidney Disease, Hemoglobin, End-Stage Renal Disease, Incident-Dialysis, Erythropoieitin, Erythropoieisis stimulating-agent, Roxadustat, AZD9941, ASP1517, FG4592
Medical subject headings
Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

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

  • RoxadustatDrug

    Also called ASP1517, AZD9941, FG-4592

    Roxadustat will be administered per dose and schedule specified in the arm.

  • Epoetin AlfaDrug

    Also called Procrit, Epogen

    Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.

Study groups in NCT02052310
Study groupRoleWhat they receive
RoxadustatExperimentalParticipants will receive roxadustat tablets, administered orally 3 times weekly (TIW). Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [≤70 kilograms (kg)] and high weight [>70 to 160 kg] participants will receive 70 and 100 milligrams [mg] roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (10-12 grams [g]/deciliter [dL]) will be based upon regular monitoring of Hb. The maximum roxadustat dose is 3.0 mg/kg per dose or 400 mg per administration (whichever is lower).
Receives: Drug: Roxadustat
Epoetin AlfaActive comparatorParticipants on hemodialysis (HD) will receive epoetin alfa, administered intravenously (IV) TIW, with starting doses and dose adjustment rules as per United States Package Insert (USPI) or summary of product characteristics (SmPC). Participants on home HD or peritoneal dialysis (PD) will receive epoetin alfa, administered subcutaneously (SC) as per the country-specific product label (USPI or SmPC) or local standard of care (SOC).
Receives: Drug: Epoetin Alfa

What is being measured

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

  1. US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)

    Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group.

    Measured: Baseline (Day 1, Week 0), Week 28 to 52

  2. Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)

    Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.

    Measured: Baseline (Day 1, Week 0) up to Week 24

Secondary outcomes (12)

  1. US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)

    Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.

    Measured: Baseline (Day 1, Week 0) up to Week 24

  2. Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population)

    Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group.

    Measured: Baseline (Day 1, Week 0), Week 28 to 52

  3. Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24

    Baseline LDL Cholesterol was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment.

    Measured: Baseline (Day 1, Week 0), Week 12 to 24

  4. Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)

    Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group.

    Measured: Baseline (Day 1, Week 0), Week 18 to 24

  5. Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52

    Monthly iron use for each participant = Total IV iron in mg / [(last dose date - first dose date of study medication in the period)+1]/ 28.

    Measured: Weeks 28 to 52

  6. Time to First RBC Transfusion

    Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates.

    Measured: Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa)

  7. Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12

    Baseline MAP was defined as the last MAP value prior to the first dose of study treatment.

    Measured: Baseline (Day 1, Week 0), Weeks 8 to 12

  8. Time to First Exacerbation of Hypertension During Weeks 28 to 52

    An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mm Hg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates.

    Measured: Weeks 28 to 52

  9. Percentage of Participants With Exacerbation of Hypertension During Weeks 28 to 52

    Percentage of participants with exacerbation of hypertension, meeting at least one of the following criteria are reported: i) Increase in BP: An increase from baseline of ≥ 20 mmHg in sBP and sBP >170 mmHg, or an increase from baseline of ≥15 mmHg dBP and dBP >100 mmHg.

    Measured: Weeks 28 to 52

  10. Time to Achieve the First Hb Response up to Week 24 Censoring for Rescue Therapy

    Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Median time to event was calculated using Kaplan Meier Survival Estimates.

    Measured: Baseline (Day 1, Week 0) up to Week 24

  11. Percentage of Participants With Hb ≥10.0 g/dL Averaged Over Weeks 28 to 36 and 28 to 52, Regardless of Rescue Therapy

    Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment.

    Measured: Weeks 28 to 36 and 28 to 52

  12. Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 36), Censoring for Rescue Therapy

    Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment.

    Measured: Baseline (Day 1, Week 0), Week 28 to 36

Timeline

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

  1. First posted3 Feb 2014 (estimated)
  2. Study start11 Feb 2014
  3. Primary completion21 Sep 2018
  4. Study completion21 Sep 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052310
Sponsor's protocol ID
FGCL-4592-063
Other IDs
2013-002753-30
Acronym
Himalayas
Status last verified
Sep 2021
First submitted
6 Jan 2014
Last updated
1 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.

    PubMed 38363466

  • Barratt J, Dellanna F, Portoles J, Choukroun G, De Nicola L, Young J, Dimkovic N, Reusch M. Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. Adv Ther. 2023 Apr;40(4):1546-1559. doi: 10.1007/s12325-023-02433-0. Epub 2023 Feb 7.

    PubMed 36749544

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roxadustat and Epoetin Alfa in people with Anemia in Incident Dialysis Patients, run by Kyntra Bio at 113 sites in 15 countries.

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 10 inclusion and 33 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Russia, Bulgaria, Romania, Ukraine and 10 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Oct 2021). 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?

US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) (time frame: Baseline (Day 1, Week 0), Week 28 to 52). The study lists 2 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 NCT02052310, which also lists 3 linked publications.

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 1 Oct 2021.

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