AKB-6548-CI-0014 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) AND AKB-6548-CI-0015 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

  • STATUS
    Recruiting
  • sponsor
    AKEBIA
Updated on 8 November 2020

Summary

AKB-6548-CI-0014 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) AND AKB-6548-CI-0015 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

Description

ANEMIA RELATED TO CHRONIC KIDNEY DISEASE. NAIVE OR CURRENTLY RECEVING ESA

Details
Clinical Study IdentifierTX144565
SponsorAKEBIA
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
AKB 014
For inclusion in the study patients should fulfill the following criteria
A subject is eligible for the study if all of the following criteria are met
Diagnosis of CKD with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m 2 using the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation during Screening (see Appendix B: CKD-EPI Creatinine Equation) and not expected to start dialysis within 6 months of Screening
Mean Screening HGB HGB < 10.0g/dL, as determined by the average of 2 HGB values measured by the central laboratory during Screening

Exclusion Criteria

Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss of the following will not qualify for entry into the study
History of prior organ transplantation or scheduled organ transplant (subjects on kidney transplant wait-list are not excluded), or prior hematopoietic stem cell or bone marrow transplant (corneal transplants and stem cell therapy for knee arthritis are not excluded)
Use of an investigational medication or participation in an investigational study within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to the Screening visit
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