At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 210 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 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)
In Brief
A Phase 2 clinical trial evaluating AKB-6548 and Placebo for Anemia and Chronic Kidney Disease. Completed, enrolled 210 participants across 47 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Chronic Kidney Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionSep 2014
TodayJul 2026
First PostedJul 24, 2013
Enrollment StartJul 23, 2013
Primary CompletionSep 3, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.9 years ago
Interventions
AKB-6548drug
Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Placebodrug
Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.