Efficacy and safety study to evaluate vadadustat for the correction of anemia in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD).
- Conditions
- Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) patientsMedDRA version: 20.0Level: LLTClassification code 10076411Term: Chronic kidney disease stage 4System Organ Class: 100000004857MedDRA version: 20.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857MedDRA version: 20.0Level: LLTClassification code 10076410Term: Chronic kidney disease stage 3System Organ Class: 100000004857Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-004265-81-HU
- Lead Sponsor
- Akebia Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1850
1. = 18 years of age
2. Diagnosis of CKD with an eGFR = 60mL/min/1.73 m² at Screening and not expected to start dialysis within 6 months of Screening
3. Mean Screening hemoglobin < 10.0 g/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 608
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 992
1. Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss
2. Any erythropoietic stimulating agent within 8 weeks prior to randomization
3. Uncontrolled hypertension
4. Severe heart failure at Screening (New York Association Class IV)
5. Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for HF, or stroke within 12 weeks prior to or during Screening
6. Hypersensitivity to darbepoetin or vadadustat, or to any of their excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Demonstrate the efficacy and safety of vadadustat compared with darbepoetin alfa for the correction and maintenance of hemoglobin in subjects with anemia secondary to NDD-CKD.;Secondary Objective: Not Applicable;Primary end point(s): Mean change in hemoglobin between baseline and the primary evaluation period;Timepoint(s) of evaluation of this end point: Baseline visit, Week 36
- Secondary Outcome Measures
Name Time Method