20-Week Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia

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)

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 patients with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Overall Status Completed
Start Date July 2013
Completion Date October 2014
Primary Completion Date October 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent of subjects achieving or maintaining a hemoglobin response as defined in the protocol. 20 weeks
Secondary Outcome
Measure Time Frame
Analysis/reanalysis of the primary endpoint with regard to hemoglobin control, need for rescue, baseline hemoglobin, and protocol-defined study groups. 20 weeks
Hematologic response to include actual values and change from baseline in hematologic parameters. 20 weeks
Need for transfusion and/or ESA rescue. 20 weeks
Safety and tolerability measures to include assessments of adverse events, vital signs, ECGs, and laboratory assay results. 20 weeks of therapy, 4 week follow-up
Enrollment 210
Condition
Intervention

Intervention Type: Drug

Intervention Name: AKB-6548

Description: Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Arm Group Label: AKB-6548

Intervention Type: Drug

Intervention Name: Placebo

Description: Oral placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 82 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Akebia Therapeutics Study Director Sponsor GmbH
Location
Facility:
| Glendale, Arizona, United States
| Tucson, Arizona, United States
| Azusa, California, United States
| Chula Vista, California, United States
| Downey, California, United States
| El Centro, California, United States
| La Mesa, California, United States
| Long Beach, California, United States
| Riverside, California, United States
| Sacramento, California, United States
| San Diego, California, United States
| Arvada, Colorado, United States
| Westminster, Colorado, United States
| Lauderdale Lakes, Florida, United States
| Port Charlotte, Florida, United States
| Tampa, Florida, United States
| Augusta, Georgia, United States
| Macon, Georgia, United States
| Meridian, Idaho, United States
| Evergreen Park, Illinois, United States
| Lafayette, Louisiana, United States
| Shreveport, Louisiana, United States
| Detroit, Michigan, United States
| Lansing, Michigan, United States
| Petoskey, Michigan, United States
| Pontiac, Michigan, United States
| Farmington, Missouri, United States
| Kansas City, Missouri, United States
| Las Vegas, Nevada, United States
| Albuquerque, New Mexico, United States
| Flushing, New York, United States
| Mineola, New York, United States
| New Rochelle, New York, United States
| Rosedale, New York, United States
| Asheville, North Carolina, United States
| Charlotte, North Carolina, United States
| Rocky Mount, North Carolina, United States
| Wilmington, North Carolina, United States
| Cincinnati, Ohio, United States
| Columbia, South Carolina, United States
| Knoxville, Tennessee, United States
| Arlington, Texas, United States
| Austin, Texas, United States
| Edinburg, Texas, United States
| Houston, Texas, United States
| San Antonio, Texas, United States
| Saint George, Utah, United States
Location Countries

United States

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: AKB-6548

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov