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)

Akebia Therapeutics0 sites210 target enrollmentJuly 23, 2013

ConditionsAnemia Chronic Kidney Disease

InterventionsAKB-6548 Placebo

Overview

Phase: Phase 2
Intervention: AKB-6548
Conditions: Anemia
Sponsor: Akebia Therapeutics
Enrollment: 210
Primary Endpoint: Percentage of Participants Achieving a Successful Hemoglobin Response
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 23, 2013

End Date

September 3, 2014

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akebia Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

AKB-6548

Intervention: AKB-6548

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Successful Hemoglobin Response

Time Frame: Weeks 19 and 20

Hemoglobin (Hgb) response was defined as participants with mean Hgb ≥11.0 grams per deciliter (g/dL) (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving Erythropoiesis-Stimulating Agents (ESA) or transfusion.

Secondary Outcomes

Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value(Weeks 19 and 20)
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group(Weeks 19 and 20)
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group(Weeks 19 and 20)
Absolute Values of Hematocrit(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study(Up to 20 Weeks)
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group(Weeks 19 and 20)
Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population(Weeks 19 and 20)
Absolute Values of Hemoglobin(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Time to First Transfusion or ESA Rescue Medication Intake(Up to 20 Weeks)
Change From Baseline in Red Blood Cell Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Number of Packed Red Blood Cell Transfusion Administered Per Participant(Up to 20 Weeks)
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings(Up to 20 Weeks)
Change From Baseline in Hematocrit(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Absolute Values of Red Blood Cell Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Absolute Values of Reticulocyte Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Percentage of Participants Who Received ESA Rescue(Up to 20 Weeks)
Mean Number of ESA Rescue Doses Administered Per Participant(Up to 20 Weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)(Up to 20 Weeks)
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values(Up to 20 Weeks)
Change From Baseline in Hemoglobin(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Change From Baseline in Reticulocyte Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue(Up to 20 Weeks)
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs(Up to 20 Weeks)
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings(Up to 20 Weeks)