NCT01381094

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

Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

Conditions

• Anemia
• Kidney Disease

Interventions

Type	Name	Description
DRUG	AKB-6548	oral dose administered once daily for 42 days
DRUG	Placebo	oral Placebo administered once daily for 42 days

Timeline

• Start date: 2011-06-15
• Primary completion: 2012-02-16
• Completion: 2012-02-16
• First posted: 2011-06-27
• Last updated: 2022-07-01
• Results posted: 2022-07-01

Locations

28 sites across 1 country: United States