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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
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.
Age
18 - 79 years
Sex
ALL
Healthy Volunteers
No
Pine Bluff, Arkansas, United States
Covina, California, United States
Los Angeles, California, United States
Lynwood, California, United States
Riverside, California, United States
San Dimas, California, United States
Whittier, California, United States
Coral Springs, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Start Date
June 15, 2011
Primary Completion Date
February 16, 2012
Completion Date
February 16, 2012
Last Updated
July 1, 2022
93
ACTUAL participants
AKB-6548
DRUG
Placebo
DRUG
Lead Sponsor
Akebia Therapeutics
NCT07241390
NCT05012111
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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