INNO2VATE-CONVERSION_Version 1.0_dated 06 May 2016
Research type
Research Study
Full title
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 (DDCKD)(INNO2VATE - CONVERSION)
IRAS ID
216434
Contact name
Sapna Shah
Contact email
Sponsor organisation
Akebia Therapeutics, Inc.
Eudract number
2016-001360-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
216434, IRAS
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The study is investigating anaemia due to dialysis dependent chronic kidney disease (DD-CKD). The study drug (vadadustat) is an investigational drug not yet approved by regulatory authorities for treating anaemia and it is being tested to treat anaemia in patients with CKD.
Anaemia is a common health problem in people with CKD. Some of the treatment may cause side effects. This study is being done to see if vadadustat which is given by mouth in the form of tablets is safe and effective in treating anemia.
The study drug works by helping the body to produce the EPO hormone which is insufficiently produced in patients with CKD.
The study is a Phase 3 study. It will focus on maintenance treatment of anaemia in patients with DD-CKD. Darbepoetin alfa has been approved to treat anaemia by regulatory authorities. It is used to treat anaemia by increasing the amount of red blood cells in the blood. Patients who qualify for the study will be randomly assigned to one of two treatment groups, vadadustat or darbepoetin alfa.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/0085
Date of REC Opinion
30 Jan 2017
REC opinion
Favourable Opinion