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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)

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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

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Mean change in Hb between baseline and the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Mean change in hemoglobin between baseline and the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  • 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) ]
Change History Complete list of historical versions of study NCT02680574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Mean change in Hb value between Baseline and the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  • Proportion of subjects with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]
  • Proportion of time with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  • Proportion of time with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  • Proportion of subjects with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  • 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) ]
  • 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) ]
  • 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 ]
  • Proportion of subjects receiving IV iron therapy [ Time Frame: Baseline visit, Week 52 ]
  • Mean monthly dose of IV elemental iron administered in subjects who have received IV iron [ Time Frame: Baseline visit, Week 52 ]
  • Proportion of subjects receiving RBC transfusion(s) [ Time Frame: Baseline visit, Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Mean change in hemoglobin value between Baseline and the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  • Proportion of subjects with mean hemoglobin within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Official Title  ICMJE 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)
Brief Summary A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Non-dialysis-dependent Chronic Kidney Disease
Intervention  ICMJE
  • Drug: vadadustat
    oral tablet
    Other Name: AKB-6548
  • Drug: darbepoetin alfa
    Subcutaneous
    Other Name: aranesp
Study Arms  ICMJE
  • Experimental: vadadustat
    Intervention: Drug: vadadustat
  • Active Comparator: darbepoetin alfa
    Intervention: Drug: darbepoetin alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 9, 2019)
1752
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
2100
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02680574
Other Study ID Numbers  ICMJE AKB-6548-CI-0015
2015-004774-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Akebia Therapeutics
Study Sponsor  ICMJE Akebia Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akebia Therapeutics Sponsor GmbH
PRS Account Akebia Therapeutics
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP