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Trials / Completed

CompletedNCT01235936

Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (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 safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Conditions

Interventions

TypeNameDescription
DRUGAKB-6548Different dose levels

Timeline

Start date
2010-10-21
Primary completion
2011-04-13
Completion
2011-05-01
First posted
2010-11-08
Last updated
2022-07-01
Results posted
2022-07-01

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01235936. Inclusion in this directory is not an endorsement.

Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia (NCT01235936) · Clinical Trials Directory