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20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Akebia Therapeutics logo

Akebia Therapeutics

Status and phase

Completed
Phase 2

Conditions

Chronic Kidney Disease
Anemia

Treatments

Drug: Placebo
Drug: AKB-6548

Study type

Interventional

Funder types

Industry

Identifiers

NCT01906489
AKB-6548-CI-0007

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

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Data sourced from clinicaltrials.gov

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