Overview

This trial is active, not recruiting.

Conditions anemia, end stage renal disease
Treatments akb-6548
Phase phase 2
Sponsor Akebia Therapeutics
Start date September 2014
End date July 2015
Trial size 90 participants
Trial identifier NCT02260193, AKB-6548-CI-0011

Summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in subjects with end stage renal disease undergoing chronic hemodialysis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
akb-6548
Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
(Experimental)
akb-6548
Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
(Experimental)
akb-6548
Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.

Primary Outcomes

Measure
Change in Baseline Hemoglobin
time frame: 8 Weeks
Change in Baseline Hemoglobin
time frame: 16 Weeks
Change in Week 8 Hemoglobin
time frame: 16 Weeks

Secondary Outcomes

Measure
Pharmacodynamic response as measured by actual values and change from baseline in hemoglobin, hematocrit, red blood cell count, and reticulocyte count.
time frame: 16 weeks
Number of subjects that require transfusion and/or ESA (erythropoiesis stimulating agent) rescue.
time frame: 16 weeks
Safety and tolerability measures to include assessments of adverse events, vital signs, electrocardiograms, and laboratory assay results.
time frame: 16 weeks of therapy and 4 weeks of follow-up
Concentration measurements of investigational product and its metabolites pre- and post-dialysis.
time frame: 2 and16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

Key Inclusion Criteria: - 18 to 79 years inclusive - Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months - Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron Key Exclusion Criteria: - BMI >44.0 kg/m2 - Transfusion within 8 weeks prior to Screening - ALT or total bilirubin >1.25x ULN - Uncontrolled hypertension - Class III or IV congestive heart failure - Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Akebia Therapeutics.