Efficacy and safety study to evaluate vadadustat for the maintenance treatment of anemia in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Phase 1

• Conditions: Anemia in chronic kidney disease patients not on dialysis; MedDRA version: 21.0Level: LLTClassification code 10076411Term: Chronic kidney disease stage 4System Organ Class: 100000004857; MedDRA version: 21.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857; MedDRA version: 21.0Level: LLTClassification code 10076410Term: Chronic kidney disease stage 3System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-004774-14-DE
• Lead Sponsor: Akebia Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-28
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1850

Inclusion Criteria

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 a dose received within 6 weeks prior to or during 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

Exclusion Criteria

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), 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
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