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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• CKD Anemia in Dialysis Participants

Interventions

Type	Name	Description
DRUG	Roxadustat	Roxadustat will be dosed orally per dose and schedule specified in the arm description.

Timeline

• Start date: 2019-06-11
• Primary completion: 2021-11-19
• Completion: 2021-12-17
• First posted: 2019-08-16
• Last updated: 2022-05-06

Locations

25 sites across 1 country: China