Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

  • Interventional
  • Recruiting
  • NCT02648347
Eligibility Details Visit Clinicaltrials.gov

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the correction of anemia and maintenance of Hb in subjects with NDD-CKD

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - ≥18 years of age

         - Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to start dialysis within 6 months of Screening

         - Mean Screening hemoglobin <10.0 g/dL

        Exclusion Criteria:

         - Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss

         - Any erythropoietic stimulating agent within 8 weeks prior to randomization

         - Uncontrolled hypertension

         - Severe heart failure at Screening (New York Heart Association Class IV)

         - 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

         - Hypersensitivity to darbepoetin or vadadustat or to any of their excipients

At a Glance

National Government IDNCT02648347

IRB#IRB17-0561

Lead SponsorAkebia Therapeutics

Lead PhysicianNicole Stankus

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting