Status:
COMPLETED
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Lead Sponsor:
Akebia Therapeutics
Conditions:
Anemia
End Stage Renal Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
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 end stage renal disease undergoing chronic he...
Eligibility Criteria
Inclusion
- Key
- 18 to 79 years inclusive
- Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
- Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron
- Key
Exclusion
- Body mass index \>44.0 kilograms per meter squared (kg/m\^2)
- Transfusion within 8 weeks prior to Screening
- Alanine transaminase or total bilirubin \>1.25x ULN
- Uncontrolled hypertension
- Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening
Key Trial Info
Start Date :
September 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT02260193
Start Date
September 10 2014
End Date
July 22 2015
Last Update
July 1 2022
Active Locations (16)
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1
El Granada, California, United States
2
Long Beach, California, United States
3
San Dimas, California, United States
4
Santa Clarita, California, United States