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Therapeutic Areas: Hematology | Family Medicine
Disease Category: Anemia
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

Purpose
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD
To Learn more

CW ID: 222916
Date Last Changed: February 3, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Akebia Therapeutics
Facility Type
N/A

Eligibility

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
  • Currently maintained on ESA therapy, with the last dose received within 8 weeks prior to Screening
  • 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

    Exclusion Criteria:

  • Uncontrolled hypertension
  • Severe heart failure at Screening (New York Heart Association Class IV)
  • Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), urgent coronary revascularization, hospitalization for CHF, or stroke within 12 weeks prior to Screening
  • Contact

    Michele Laney
    University of South Florida - Morsani Center for Advanced Healthcare
    13330 USF Laurel Dr
    Tampa, FL 33612
    Phone: (813) 396-9179

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