16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Subjects With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

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.

Sponsors

Lead Sponsor: Akebia Therapeutics

Source Akebia Therapeutics
Brief 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.

Overall Status Completed
Start Date September 2014
Completion Date August 2015
Primary Completion Date July 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Baseline Hemoglobin 8 Weeks
Change in Baseline Hemoglobin 16 Weeks
Change in Week 8 Hemoglobin 16 Weeks
Secondary Outcome
Measure Time Frame
Pharmacodynamic response as measured by actual values and change from baseline in hemoglobin, hematocrit, red blood cell count, and reticulocyte count. 16 weeks
Number of subjects that require transfusion and/or ESA (erythropoiesis stimulating agent) rescue. 16 weeks
Safety and tolerability measures to include assessments of adverse events, vital signs, electrocardiograms, and laboratory assay results. 16 weeks of therapy and 4 weeks of follow-up
Concentration measurements of investigational product and its metabolites pre- and post-dialysis. 2 and16 weeks
Enrollment 94
Condition
Intervention

Intervention Type: Drug

Intervention Name: AKB-6548

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

Arm Group Label: AKB-6548, starting dose 1

Intervention Type: Drug

Intervention Name: AKB-6548

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

Arm Group Label: AKB-6548, starting dose 2

Intervention Type: Drug

Intervention Name: AKB-6548

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

Arm Group Label: AKB-6548, starting dose 3

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
S. Akebia Therapeutics, Pharm.D. Study Director Sponsor GmbH
Location
Facility:
| El Granada, California, United States
| Long Beach, California, United States
| San Dimas, California, United States
| Santa Clarita, California, United States
| Whittier, California, United States
| Arvada, Colorado, United States
| Westminster, Colorado, United States
| Naples, Florida, United States
| North Miami Beach, Florida, United States
| Augusta, Georgia, United States
| Astoria, New York, United States
| Arlington, Texas, United States
| Grand Prairie, Texas, United States
| Greenville, Texas, United States
| Houston, Texas, United States
| Mechanicsville, Virginia, United States
Location Countries

United States

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: AKB-6548, starting dose 1

Type: Experimental

Label: AKB-6548, starting dose 2

Type: Experimental

Label: AKB-6548, starting dose 3

Type: Experimental

Patient Data Undecided
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov