Pro2tect-Correction _ Version 2.0 Amendment 1 _ 17 March 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 correction of anemia in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) (PRO2TECT-CORRECTION)
IRAS ID
206738
Contact name
Mohsen El Kossi
Contact email
Sponsor organisation
Akebia Therapeutics, Inc.
Eudract number
2015-004265-81
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study is investigating anaemia due to non-dialysis dependent chronic kidney disease. The study drug (vadadustat) is an investigational drug not yet approved by regulatory authorities for treating anaemia. It will be referred to as the “study drug” in this document, and any treatment in the study (including the study drug) may be referred to as “study medication”.It is being tested to treat anaemia in patients with chronic kidney disease. \n\nAnaemia is a common health problem in people with chronic kidney disease. This is because healthy kidneys produce hormone called erythropoietin that helps to have the appropriate number of red cells. Patients with anaemia have lower than normal number of red cells with a low level of a protein called haemoglobin. This is the protein that carries oxygen from the lung to different body tissues and organs. Anaemia can make you feel tired and weak with shortness of breath, and trouble fighting off infections.\n\nMany medications are available to treat anaemia. The commonly used one used in chronic kidney disease as a replacement of the hormone erythropoietin is given by injections under the skin.\n\nSome of these treatments may cause side effects in some patients. This study is being done to see if the investigational drug (vadadustat) which is given by mouth in the form of tablets is safe and effective in treating anaemia and has fewer side effects than a currently used prescription medication (erythropoeitin which in this study is called darbepoetin). \nThe study drug works by helping the body to produce the erythropoietin (or EPO) hormone which is insufficiently produced in patients with chronic kidney disease.\n\nThe study is a Phase 3 study. The study will focus on the treatment of anaemia in patients with chronic kidney disease. 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. Darbepoetin alfa is given as an injection just under the skin. Patients who qualify for the study will be randomly assigned to one of two treatment groups, vadadustat or darbepoetin alfa.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0620
Date of REC Opinion
19 Oct 2016
REC opinion
Further Information Favourable Opinion