CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,751 enrolled
Drug / intervention
Vadadustat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02648347
NCT02648347Phase 3Completed
CompareCT.gov

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)

Akebia Therapeutics·interventional·Posted Jan 7, 2016·Updated Jun 27, 2022

In Brief

A Phase 3 clinical trial evaluating Vadadustat and Darbepoetin alfa for Anemia and Non-Dialysis-Dependent Chronic Kidney Disease. Completed, enrolled 1,751 participants across 439 sites in 20 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Non-Dialysis-Dependent Chronic Kidney Disease
CountriesArgentina, Australia, Brazil, Bulgaria, France, Hungary, Israel, Italy, Malaysia, Mexico, New Zealand, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 7, 2016
Enrollment StartDec 1, 2015
Primary CompletionJun 4, 2020
Study CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.5 years ago

Interventions

Vadadustatdrug

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Darbepoetin alfadrug

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.