- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059913
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Beijing, China, 100044
- Investigational Site
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Beijing, China, 100191
- Investigational Site
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Beijing, China, 100730
- Investigational Site
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Shanghai, China, 200025
- Investigational Site
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Tianjin, China, 300052
- Investigational Site
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Anhui
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Hefei, Anhui, China, 230601
- Investigational Site
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Gansu
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Lanzhou, Gansu, China, 730030
- Investigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Investigational Site
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Shenzhen, Guangdong, China, 518020
- Investigational Site
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Guangxi Province
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Nanning, Guangxi Province, China, 530021
- Investigational Site
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Henan
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Zhengzhou, Henan, China, 450052
- Investigational Site
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Hubei
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Wuhan, Hubei, China, 430060
- Investigational Site
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Hunan
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Changsha, Hunan, China, 410008
- Investigational Site
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Inner Mongolia Autonomous Region
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Baotou, Inner Mongolia Autonomous Region, China, 014010
- Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Investigational Site
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- Investigational Site
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Jilin
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Chang chun, Jilin, China, 130021
- Investigational Site
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Liaoning
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Shenyang, Liaoning, China, 110004
- Investigational Site
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Shenyang, Liaoning, China, 110122
- Investigational Site
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Shanxi
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Taiyuan, Shanxi, China, 030001
- Investigational Site
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Xi'an, Shanxi, China, 710004
- Investigational Site
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Xi'an, Shanxi, China, 710061
- Investigational Site
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Sichuan
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Chengdu, Sichuan, China, 610041
- Investigational Site
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Chengdu, Sichuan, China, 610072
- Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: ESA-Naïve Participants - Low Weight Based Dosing
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 1: ESA-Naïve Participants - Standard Weight Based Dosing
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 1: ESA-Treated Participants - Low Weight Based Dosing
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 1: ESA-Treated Participants - Standard Weight Based Dosing
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 2: Roxadustat QW
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 2: Roxadustat BIW
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.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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Experimental: Part 2: Roxadustat TIW
Participants will receive roxadustat TIW.
Roxadustat dose will continue per dose adjustment guideline.
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Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Time Frame: Weeks 1 to 20
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Weeks 1 to 20
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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
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Weeks 17 to 21
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Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Time Frame: Weeks 33 to 37
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Weeks 33 to 37
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Time Frame: Baseline, Weeks 17 to 21
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Baseline, Weeks 17 to 21
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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
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Weeks 17 to 21
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Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Time Frame: Weeks 33 to 37
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Weeks 33 to 37
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FGCL-4592-818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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