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Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

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ClinicalTrials.gov Identifier: NCT02865850
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

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

Condition or disease Intervention/treatment Phase
Anemia 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 or maintenance treatment in subjects with anemia secondary to CKD who have recently initiated dialysis treatment for end-stage renal disease.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)
Study Start Date : July 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 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/intravenous
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. AEs and SAEs [ Time Frame: 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 Week s24-36 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
  • Mean Screening hemoglobin between 8.0 and <11.0 g/dL (inclusive)

Exclusion Criteria:

  • Subjects meeting the criteria of ESA resistance within 8 weeks prior to or during Screening defined as follows

    1. epoetin: > 7700 units/dose three times per week or >23,000 units per week
    2. darbepoetin alfa: >100 mcg/week
    3. methoxy polyethylene glycol-epoetin beta: >100 mcg every other week or >200 mcg/month
  • Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss
  • Anticipated to recover adequate kidney function to no longer require dialysis
  • Uncontrolled hypertension
  • Severe heart failure at Screening (New York Heart Association Class IV)
  • Acute coronary syndrome (hospitalization for unstable angina, 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 CHF; or stroke within 12 weeks prior to or during Screening.
  • Hypersensitivity to vadadustat, darbepoetin alfa or 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): NCT02865850


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

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Sponsors and Collaborators
Akebia Therapeutics
Investigators
Study Director: Akebia Therapeutics Sponsor GmbH

Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT02865850     History of Changes
Other Study ID Numbers: AKB-6548-CI-0016
2016-000838-21 ( EudraCT Number )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Akebia Therapeutics:
anemia
oral anemia treatment
vadadustat
AKB-6548
chronic kidney disease
CKD
chronic renal insufficiency
renal impairment
erythropoietin
kidney
renal
hemoglobin
hypoxia-inducible factor
HIF
efficacy
safety
phase 3
cardiovascular

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics