20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Status and phase
Completed
Phase 2
Conditions
Chronic Kidney Disease
Anemia
Treatments
Drug: Placebo
Drug: AKB-6548
Details and patient eligibility
About
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.
Enrollment
210 patients
Sex
All
Ages
18 to 82 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- 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 Criteria:
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
210 participants in 2 patient groups, including a placebo group
AKB-6548
Experimental group
Treatment:
Drug: AKB-6548
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
47
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems