Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

NCT01235936 | Completed Phase 2 Results

• 1 other identifier: AKB-6548-CI-0004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Conditions

Anemia; Kidney Disease

Keywords

anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Hemoglobin (Hgb) on Day 29

  Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.

  Baseline; Day 29

Secondary Outcomes (19)

• Mean Change From Baseline in Hematocrit on Day 29

  Baseline; Day 29

• Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29

  Baseline; Day 29

• Mean Change From Baseline in Absolute Reticulocyte Count on Day 29

  Baseline; Day 29

• Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29

  Baseline; Day 29

• Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29

  Day 29

Study Arms (1)

AKB-6548

EXPERIMENTAL

Drug: AKB-6548

Interventions

AKB-6548 DRUG

Different dose levels

AKB-6548

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 79 years of age, inclusive
• Chronic Kidney Disease Stage 3 or Stage 4
• Hemoglobin (Hgb) \< 10.5 g/dl
• TSAT \> 20% and CBC indicating normocytic red blood cell morphology

You may not qualify if:

• BMI \> 40
• Red blood cell transfusion within 12 weeks.
• Androgen therapy within the previous 21 days prior to study dosing
• Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
• Participants meeting the criteria of ESA resistance within the previous 4 months
• Individual doses of intravenous iron of 250 mg or larger within the past 21 days
• AST or ALT \>1.8x ULN.
• Alkaline phosphatase \>2x ULN.
• Total bilirubin \>1.5x ULN.
• Uncontrolled hypertension
• New York Heart Association Class III or IV congestive heart failure
• Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (2)

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Anemia; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This pilot study planned to include 15 participants with either Stage 3 or 4 CKD, with no minimum or maximum enrollment target for either stage; however, because of slow enrollment the Sponsor terminated the study early after only 10 participants had enrolled. The overall status of the study was considered as completed since 10 participants received Vadadustat and all 10 participants completed the study per protocol.

Results Point of Contact

• Title: Akebia Therapeutics, Inc
• Organization: Akebia Therapeutics, Inc

trials@akebia.com

617-844-6128

Study Officials

• Chief Medical Officer

  Akebia Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: October 21, 2010
• Primary Completion: April 13, 2011
• Study Completion: May 1, 2011
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)