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

NCT01906489 | Completed Phase 2 Results

• 1 other identifier: AKB-6548-CI-0007
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 47

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI; efficacy; safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Successful Hemoglobin Response

  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.

  Weeks 19 and 20

Secondary Outcomes (24)

• 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, 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

• Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group

  Weeks 19 and 20

Other Outcomes (22)

• Exploratory: Change From Baseline in Iron and Total Iron Binding Capacity (TIBC)

  Baseline and up to Week 20

• Exploratory: Change From Baseline in Transferrin

  Baseline and up to Week 20

• Exploratory: Change From Baseline in Transferrin Saturation

  Baseline and up to Week 20

Study Arms (2)

AKB-6548

EXPERIMENTAL

Drug: AKB-6548

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AKB-6548 DRUG

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

AKB-6548

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (47)

Unknown Facility

Glendale, Arizona, United States

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Tucson, Arizona, United States

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Azusa, California, United States

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Chula Vista, California, United States

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Downey, California, United States

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El Centro, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Arvada, Colorado, United States

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Westminster, Colorado, United States

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Lauderdale Lakes, Florida, United States

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Port Charlotte, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Meridian, Idaho, United States

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Evergreen Park, Illinois, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Petoskey, Michigan, United States

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Pontiac, Michigan, United States

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Farmington, Missouri, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Flushing, New York, United States

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Mineola, New York, United States

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New Rochelle, New York, United States

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Rosedale, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbia, South Carolina, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

Location

Related Publications (2)

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

  PMID: 36005278 DERIVED

• Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int. 2016 Nov;90(5):1115-1122. doi: 10.1016/j.kint.2016.07.019. Epub 2016 Sep 17.

  PMID: 27650732 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney 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

Results Point of Contact

• Title: Akebia Therapeutics
• Organization: Akebia Therapeutics

trials@akebia.com

617-844-6128

Study Officials

• Chief Medical Officer

  Akebia Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 24, 2013
• Study Start: July 23, 2013
• Primary Completion: September 3, 2014
• Study Completion: September 3, 2014
• Last Updated: July 21, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (47)