Status:
COMPLETED
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Lead Sponsor:
Akebia Therapeutics
Conditions:
Anemia
Kidney Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Key
- 18 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01235936
Start Date
October 21 2010
End Date
May 1 2011
Last Update
July 1 2022
Active Locations (2)
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1
Augusta, Georgia, United States
2
San Antonio, Texas, United States