At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 enrolled
Drug / intervention
AKB-6548 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AKB-6548 and Placebo for Anemia and Kidney Disease. Completed, enrolled 93 participants across 28 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Kidney Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionFeb 2012
TodayJul 2026
First PostedJun 27, 2011
Enrollment StartJun 15, 2011
Primary CompletionFeb 16, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.0 years ago
Interventions
AKB-6548drug
oral dose administered once daily for 42 days
Placebodrug
oral Placebo administered once daily for 42 days