Trials / Completed
CompletedNCT02648347
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,751 (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 correction of anemia and maintenance of hemoglobin (Hb) 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 correction of anemia and maintenance of Hb 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. |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2020-06-04
- Completion
- 2020-07-31
- First posted
- 2016-01-07
- Last updated
- 2022-06-27
- Results posted
- 2022-06-27
Locations
439 sites across 20 countries: United States, Argentina, Australia, Brazil, Bulgaria, France, Hungary, Israel, Italy, Malaysia, Mexico, New Zealand, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02648347. Inclusion in this directory is not an endorsement.