NCT01888445

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.

Detailed description

To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia. To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in dialysis chronic kidney disease patients with anemia.

Conditions

• Renal Anemia Associated With Chronic Renal Failure (CRF)

Interventions

Type	Name	Description
DRUG	roxadustat	oral
DRUG	darbepoetin alfa	iv

Timeline

• Start date: 2013-03-28
• Primary completion: 2014-09-15
• Completion: 2014-09-15
• First posted: 2013-06-27
• Last updated: 2024-10-30

Locations

8 sites across 1 country: Japan