Status:
COMPLETED
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Lead Sponsor:
Akebia Therapeutics
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18-82 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 Chronic Kidney Disease (pre-dialysis) with an...
Eligibility Criteria
Inclusion
- Key
- 18 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
July 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01906489
Start Date
July 23 2013
End Date
September 3 2014
Last Update
July 21 2022
Active Locations (47)
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1
Glendale, Arizona, United States
2
Tucson, Arizona, United States
3
Azusa, California, United States
4
Chula Vista, California, United States