Trials / Completed
CompletedNCT02892149
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
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 Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,554 (actual)
- Sponsor
- Akebia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-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 participants with DD-CKD
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vadadustat | Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. |
| DRUG | Darbepoetin alfa | Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2020-01-16
- Completion
- 2020-03-30
- First posted
- 2016-09-08
- Last updated
- 2022-06-28
- Results posted
- 2022-06-28
Locations
278 sites across 18 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, France, Germany, Israel, Italy, Mexico, Poland, Portugal, Russia, Serbia, South Korea, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02892149. Inclusion in this directory is not an endorsement.