NCT01906489

20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Participants With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Conditions

• Anemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	AKB-6548	Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
DRUG	Placebo	Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Timeline

• Start date: 2013-07-23
• Primary completion: 2014-09-03
• Completion: 2014-09-03
• First posted: 2013-07-24
• Last updated: 2022-07-21
• Results posted: 2022-07-01

Locations

47 sites across 1 country: United States