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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics
ClinicalTrials.gov Identifier:
NCT01381094
First received: June 23, 2011
Last updated: October 3, 2012
Last verified: October 2012

June 23, 2011
October 3, 2012
June 2011
February 2012   (final data collection date for primary outcome measure)
Mean absolute change in hemoglobin. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01381094 on ClinicalTrials.gov Archive Site
  • Hematologic response to include rate of response, actual values, change from baseline, and maximum change in hematologic parameters. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Safety and tolerability measures will include assessments of adverse events, vital signs, ECGs, physical exam findings, and laboratory assays (hematology and chemistry). [ Time Frame: 42 days of therapy, 2 week follow-up ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic assessment will involve both pre-dose and post-dose plasma concentration of AKB-6548. [ Time Frame: Weeks 2 and 4 visits ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
42-Day Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4

The purpose of this study is to evaluate the dose response (efficacy), safety, and tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat dosing for 42 days.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Kidney Disease
  • Drug: AKB-6548
    oral dose administered once daily for 42 days
  • Drug: Placebo
    oral placebo administered once daily for 42 days
  • Experimental: AKB-6548 240 mg
    Intervention: Drug: AKB-6548
  • Experimental: AKB-6548 370 mg
    Intervention: Drug: AKB-6548
  • Experimental: AKB-6548 500 mg
    Intervention: Drug: AKB-6548
  • Experimental: AKB-6548 630 mg
    Intervention: Drug: AKB-6548
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
March 2012
February 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 18 to 79 years of age, inclusive
  • Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
  • Hemoglobin (Hgb) ≤ 10.5 g/dL
  • TSAT ≥ 20%
  • Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

  • BMI >42
  • 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 11 weeks prior to the Screening visit
  • Subjects meeting the criteria of ESA resistance within the previous 4 months
  • Individual doses of intravenous iron of greater than 250 mg 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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01381094
AKB-6548-CI-0005
No
Akebia Therapeutics
Akebia Therapeutics
Not Provided
Study Chair: Robert Shalwitz, MD Akebia Therapeutics
Akebia Therapeutics
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP