Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, multi-center study in dialysis CKD subjects to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.

There are three 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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen

Criteria

Inclusion Criteria:

1. Chronic kidney disease with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)

Exclusion Criteria:

1. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).

2. Cardiovascular risks such as: myocardial infarction, stroke, heart failure or a thromboembolic event (e.g., deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.

3. History of malignancy, myelodysplastic syndrome, and multiple myeloma.

4. Disease conditions that could impact red blood cell production.

5. Recent blood loss (i.e clinically significant gastrointestinal bleeding).

6. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.