Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680574
Recruitment Status : Active, not recruiting
First Posted : February 11, 2016
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Brief Summary:
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD

Condition or disease Intervention/treatment Phase
Anemia Non-dialysis-dependent Chronic Kidney Disease Drug: vadadustat Drug: darbepoetin alfa Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vadadustat Drug: vadadustat
oral tablet
Other Name: AKB-6548

Active Comparator: darbepoetin alfa Drug: darbepoetin alfa
Subcutaneous
Other Name: aranesp




Primary Outcome Measures :
  1. Mean change in Hb between baseline and the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  2. Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]

Secondary Outcome Measures :
  1. Mean change in Hb value between Baseline and the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  2. Proportion of subjects with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  3. Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]
  4. Proportion of time with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  5. Proportion of time with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  6. Proportion of subjects with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  7. Proportion of subjects with Hb increase of >1.0 g/dL from Baseline visit [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  8. Time to achieve Hb increase of 1.0 g/dL from Baseline visit [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  9. Mean change in Hb between Baseline (mean pretreatment Hb) and the primary evaluation period (mean Hgb from weeks 24-36) stratified b pre-baseline ESA exposure [ Time Frame: Baseline visit, Week 36 ]
  10. Proportion of subjects receiving IV iron therapy [ Time Frame: Baseline visit, Week 52 ]
  11. Mean monthly dose of IV elemental iron administered in subjects who have received IV iron [ Time Frame: Baseline visit, Week 52 ]
  12. Proportion of subjects receiving RBC transfusion(s) [ Time Frame: Baseline visit, Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 a dose received within 6 weeks prior to or during 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), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680574


  Show 503 Study Locations
Sponsors and Collaborators
Akebia Therapeutics
Investigators
Layout table for investigator information
Study Director: Akebia Therapeutics Sponsor GmbH

Layout table for additonal information
Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT02680574     History of Changes
Other Study ID Numbers: AKB-6548-CI-0015
2015-004774-14 ( EudraCT Number )
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akebia Therapeutics:
vadadustat
AKB-6548
Chronic kidney disease
anemia
CKD
chronic renal insufficiency
renal impairment
erythropoietin
kidney
renal
oral anemia treatment
hemoglobin
hypoxia-inducible factor
HIF
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
efficacy
safety
Phase 3
cardiovascular
NDD-CKD
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Glycine
Hematinics
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs