CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 369 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/NCT02865850
NCT02865850Phase 3Completed
CompareCT.gov

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)

Akebia Therapeutics·interventional·Posted Aug 15, 2016·Updated Jul 18, 2022

In Brief

A Phase 3 clinical trial evaluating Vadadustat and Darbepoetin alfa for Anemia and Dialysis-Dependent Chronic Kidney Disease. Completed, enrolled 369 participants across 118 sites in 11 countries.

Detailed Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Dialysis-Dependent Chronic Kidney Disease
CountriesArgentina, Brazil, Germany, Italy, Mexico, Poland, Portugal, Russia, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 15, 2016
Enrollment StartJul 1, 2016
Primary CompletionJan 31, 2020
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.9 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. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.