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

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ClinicalTrials.gov Identifier: NCT02648347
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Brief Summary:
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

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 correction of anemia and maintenance of Hb in subjects with NDD-CKD

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 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 Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
Study Start Date : December 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  8. Time to achieve Hb increase of >1.0g/dL from Baseline [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  9. Mean change in Hb between Baseline (mean pretreatment Hgb) and the primary evaluation period (mean Hgb from Weeks 24-36) stratified by 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • 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

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): NCT02648347


Contacts
Contact: Akebia Therapeutics 617-844-6128 trials@akebia.com

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Sponsors and Collaborators
Akebia Therapeutics

Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT02648347     History of Changes
Other Study ID Numbers: AKB-6548-CI-0014
2015-004265-81 ( EudraCT Number )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics