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)

NCT04655027

Phase 4 Completed 25 enrolled AstraZeneca Parexel · collab
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

EvaluationDrugModalityDoseRoute
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