drugset / Trial / NCT04655027
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.
Timeline
- Start
- 2021-02-22
- Primary completion
- 2021-10-12
- Completion
- 2021-10-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roxadustat | Small molecule | 70 mg | Oral |
| Subject | Roxadustat | Small molecule | 100 mg | Oral |
| Subject | Roxadustat | Small molecule | 120 mg | Oral |
| Comparator | epoetin alfa | Protein / enzyme biologic | 6000 iu | Intravenous |