200808 Anaemia of CKD (non-dialysis): daprodustat vs darbepoetin alfa
Research type
Research Study
Full title
A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
IRAS ID
210511
Contact name
Indranil Dasgupta
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2016-000542-65
Duration of Study in the UK
4 years, 7 months, 12 days
Research summary
When kidneys are diseased or damaged, they do not make enough erythropoietin, a hormone which stimulates bone marrow to produce blood. As a result, the bone marrow makes fewer red blood cells, causing anaemia. Daprodustat is currently being investigated as a treatment for anaemia associated with Chronic Kidney Disease (CKD).
Both pre-clinical and clinical data show that daprodustat stimulates erythropoietin production, resulting in increased haemoglobin concentrations. It is thought that due to a slightly different mechanism of action, daprodustat may not cause as many adverse effects, such as raised blood pressure, with which similar treatments that are currently in use can be associated.
Adequate safety and efficacy has been demonstrated in clinical trials where patients have taken daprodustat for up to 24 weeks.
This study will test how effective and safe daprodustat (a pill) is compared to darbepoetin alfa (an injection) for the treatment of anaemia associated with CKD in patients not on dialysis over a long period of time. About 4500 people in about 40 countries will take part in this study. Participants and their study doctor will know which treatment they are receiving. The length of time participants will be in the study could be up to 4 years.
During the study the following will be documented/completed: medical history, height, weight, blood pressure, heart rate, blood and urine tests, questionnaires, ultrasound, electrocardiogram (ECG), changes to medicines and details of any adverse events.
Visits are every 2 weeks for the first month, 4 weeks apart for the first year and at least every 12 weeks for the rest of the study. Additional visits may be required if they are needed.The study is being sponsored by GlaxoSmithKline.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0396
Date of REC Opinion
9 Nov 2016
REC opinion
Further Information Favourable Opinion