CKD Anemia in Dialysis ParticipantsPhase 4NCT04059913
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
A Phase 4 study testing Roxadustat in people with CKD Anemia in Dialysis Participants, run by Kyntra Bio at 25 sites in China.
Trial summary
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CKD Anemia in Dialysis Participants
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 25 sitesChina
- Study dates
- 11 Jun 2019to 17 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 1. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Who cannot join
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
- History of malignancy, myelodysplastic syndrome, and multiple myeloma.
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
- Clinically significant gastrointestinal bleeding.
- Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Investigational Site
Baotou, Inner Mongolia, 014010
Investigational Site
Beijing, 100044
Investigational Site
Beijing, 100191
Investigational Site
Beijing, 100730
Investigational Site
Changchun, Jilin, 130021
Investigational Site
Changsha, Hunan, 410008
Investigational Site
Chengdu, Sichuan, 610041
Investigational Site
Chengdu, Sichuan, 610072
Investigational Site
Guangzhou, Guangdong, 510515
Investigational Site
Hangzhou, Zhejiang, 310003
Investigational Site
Hefei, Anhui, 230601
Investigational Site
Lanzhou, Gansu, 730030
Investigational Site
Nanchang, Jiangxi, 330006
Investigational Site
Nanjing, Jiangsu, 210009
Investigational Site
Nanning, Guangxi, 530021
Investigational Site
Shanghai, 200025
Investigational Site
Shenyang, Liaoning, 110004
Investigational Site
Shenyang, Liaoning, 110122
Investigational Site
Shenzhen, Guangdong, 518020
Investigational Site
Taiyuan, Shanxi, 030001
Investigational Site
Tianjin, 300052
Investigational Site
Wuhan, Hubei, 430060
Investigational Site
Xi’an, Shanxi, 710004
Investigational Site
Xi’an, Shanxi, 710061
Investigational Site
Zhengzhou, Henan, 450052
About this study
Official title: A Prospective, Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
There are 3 study periods:
- Screening Period (up to 4 weeks)
- Treatment Period (36 weeks)
Part 1: Correction/Conversion Period (Weeks 1-20)
Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)
- Follow-up Period (4 weeks)
Read the detailed description
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:
- Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight <60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg
- Standard weight-based dosing: 100 mg TIW for body weight <60 kg or 120 mg TIW for body weight ≥60 kg
After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.
At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.
- Conditions
- CKD Anemia in Dialysis Participants
- Being tested
- Roxadustat
- Keywords
- Anemia, Chronic Kidney Disease Dialysis, hemoglobin, End stage renal disease
- Medical subject headings
- Anemia, 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 FG-4592
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ESA-Naïve Participants - Low Weight Based Dosing | Experimental | ESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. Receives: Drug: Roxadustat |
| Part 1: ESA-Naïve Participants - Standard Weight Based Dosing | Experimental | ESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. Receives: Drug: Roxadustat |
| Part 1: ESA-Treated Participants - Low Weight Based Dosing | Experimental | ESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. Receives: Drug: Roxadustat |
| Part 1: ESA-Treated Participants - Standard Weight Based Dosing | Experimental | ESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. Receives: Drug: Roxadustat |
| Part 2: Roxadustat QW | Experimental | Participants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount. Receives: Drug: Roxadustat |
| Part 2: Roxadustat BIW | Experimental | Participants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount. Receives: Drug: Roxadustat |
| Part 2: Roxadustat TIW | Experimental | Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline. Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Measured: Weeks 1 to 20
Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits
Measured: Weeks 17 to 21
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Measured: Weeks 33 to 37
Secondary outcomes (3)
Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Measured: Baseline, Weeks 17 to 21
Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L
Measured: Weeks 17 to 21
Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Measured: Weeks 33 to 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start11 Jun 2019
- Primary completion19 Nov 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKD Anemia in Dialysis ParticipantsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059913
- Sponsor's protocol ID
- FGCL-4592-818
- Status last verified
- May 2022
- First submitted
- 8 Aug 2019
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04059913
- Acronym / sponsor ID
- FGCL-4592-818
- Conditions
- CKD Anemia in Dialysis Participants
- Keywords
- Anemia, Chronic Kidney Disease Dialysis, hemoglobin, End stage renal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
There are 3 study periods:
- Screening Period (up to 4 weeks)
- Treatment Period (36 weeks)
Part 1: Correction/Conversion Period (Weeks 1-20)
Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)
- Follow-up Period (4 weeks)
Detailed description
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:
- Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight <60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg
- Standard weight-based dosing: 100 mg TIW for body weight <60 kg or 120 mg TIW for body weight ≥60 kg
After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.
At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: ESA-Naïve Participants - Low Weight Based Dosing | Experimental | Drug: RoxadustatESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. |
| Part 1: ESA-Naïve Participants - Standard Weight Based Dosing | Experimental | Drug: RoxadustatESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. |
| Part 1: ESA-Treated Participants - Low Weight Based Dosing | Experimental | Drug: RoxadustatESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. |
| Part 1: ESA-Treated Participants - Standard Weight Based Dosing | Experimental | Drug: RoxadustatESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. |
| Part 2: Roxadustat QW | Experimental | Drug: RoxadustatParticipants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount. |
| Part 2: Roxadustat BIW | Experimental | Drug: RoxadustatParticipants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount. |
| Part 2: Roxadustat TIW | Experimental | Drug: RoxadustatParticipants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Key exclusion criteria (6 listed)
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
- History of malignancy, myelodysplastic syndrome, and multiple myeloma.
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
- Clinically significant gastrointestinal bleeding.
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 dosed orally per dose and schedule specified in the arm description. | Drug | Part 1: ESA-Naïve Participants - Low Weight Based Dosing, Part 1: ESA-Naïve Participants - Standard Weight Based Dosing, Part 1: ESA-Treated Participants - Low Weight Based Dosing, Part 1: ESA-Treated Participants - Standard Weight Based Dosing, Part 2: Roxadustat BIW, Part 2: Roxadustat QW, Part 2: Roxadustat TIW |
Primary outcome
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Time frame: Weeks 1 to 20
Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits
Time frame: Weeks 17 to 21
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Time frame: Weeks 33 to 37
3 secondary outcomes
Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Time frame: Baseline, Weeks 17 to 21
Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L
Time frame: Weeks 17 to 21
Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Time frame: Weeks 33 to 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roxadustat in people with CKD Anemia in Dialysis Participants, run by Kyntra Bio at 25 sites in China.
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 1 inclusion and 6 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 6 May 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks (time frame: Weeks 1 to 20). 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 NCT04059913, 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 6 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.