Overview

This trial is active, not recruiting.

Conditions anemia, chronic kidney disease
Treatments akb-6548, placebo
Phase phase 2
Sponsor Akebia Therapeutics
Start date July 2013
End date October 2014
Trial size 200 participants
Trial identifier NCT01906489, AKB-6548-CI-0007

Summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
akb-6548
Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
(Placebo Comparator)
placebo
Oral placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Primary Outcomes

Measure
Percent of subjects achieving or maintaining a hemoglobin response as defined in the protocol.
time frame: 20 weeks

Secondary Outcomes

Measure
Analysis/reanalysis of the primary endpoint with regard to hemoglobin control, need for rescue, baseline hemoglobin, and protocol-defined study groups.
time frame: 20 weeks
Hematologic response to include actual values and change from baseline in hematologic parameters.
time frame: 20 weeks
Need for transfusion and/or ESA rescue.
time frame: 20 weeks
Safety and tolerability measures to include assessments of adverse events, vital signs, ECGs, and laboratory assay results.
time frame: 20 weeks of therapy, 4 week follow-up

Eligibility Criteria

Male or female participants from 18 years up to 82 years old.

Key Inclusion Criteria: - 18 to 82 years of age, inclusive - Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis - eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2 - Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol - Iron replete with ferritin and TSAT levels as defined per protocol Key Exclusion Criteria: - BMI > 44.0 kg/m2 - Red blood cell transfusion within 11 weeks prior to the Screening visit - Androgen therapy within the previous 21 days prior to the Screening visit - Intravenous iron within the past 4 weeks prior to the Screening visit - AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN - Screening ECG with QTc > 500 msec - Uncontrolled hypertension - Class III or IV congestive heart failure - Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit

Additional Information

Official title 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 Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Akebia Therapeutics.