Efficacy and safety study to evaluate vadadustat for the maintenance treatment of anemia in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD).
- Conditions
- Anemia in chronic kidney disease patients not on dialysisMedDRA version: 19.0Level: LLTClassification code 10076411Term: Chronic kidney disease stage 4System Organ Class: 100000004857MedDRA version: 19.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857MedDRA version: 19.0Level: LLTClassification code 10076410Term: Chronic kidney disease stage 3System Organ Class: 100000004857Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-004774-14-ES
- Lead Sponsor
- Akebia Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1725
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. Currently maintained on ESA therapy, with the last dose received within 8 weeks prior to Screening
4. Mean Screening HGB between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
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 798
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1302
1. Uncontrolled hypertension
2. Severe heart failure at Screening (New York Association Class IV)
3. Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), urgent coronary revascularisation, hospitalization for Congestive Heart Failure (CHF), or stroke within 12 weeks prior to Screening
4. 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 maintenance treatment of anemia in subjects with NDD-CKD after conversion from current ESA therapy;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 Secondary end point(s): Efficacy<br>1. Mean change in hemoglobin value between Baseline and the secondary evaluation period<br>2. Proportion of subjects with mean HGB within the target range during the primary evaluation period <br>Safety<br>3. Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke<br>4. Individual components of MACE<br>5. AEs and SAEs;Timepoint(s) of evaluation of this end point: 1. Baseline visit, Week 52<br>2. Baseline visit, Week 36<br>3. Baseline to end of study<br>4. Baseline to end of study<br>5. Baseline to end of study