CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
AKB-6548 +2 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.

Search/NCT02260193
NCT02260193Phase 2Completed
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Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.

Akebia Therapeutics·interventional·Posted Oct 9, 2014·Updated Jul 1, 2022

In Brief

A Phase 2 clinical trial evaluating AKB-6548 for Anemia and End Stage Renal Disease. Completed, enrolled 94 participants across 16 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 end stage renal disease undergoing chronic hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, End Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartSep 10, 2014
Primary CompletionJul 22, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.7 years ago

Interventions

AKB-6548drug

Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

AKB-6548drug

Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

AKB-6548drug

Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.