Trials / Completed
CompletedNCT02680574
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-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 Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,725 (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 Non-dialysis-dependent Chronic Kidney Disease (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 participants with NDD-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
- 2016-02-01
- Primary completion
- 2020-06-18
- Completion
- 2020-07-31
- First posted
- 2016-02-11
- Last updated
- 2022-06-27
- Results posted
- 2022-06-27
Locations
503 sites across 30 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02680574. Inclusion in this directory is not an endorsement.