ASCEND-ID
Research type
Research Study
Full title
ASCEND-ID: A 52-week open-label (sponsor-blind), randomized, active-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of daprodustat compared to recombinant human erythropoietin in subjects with anaemia associated with chronic kidney disease who are initiating dialysis.
IRAS ID
220645
Contact name
Indranil Dasgupta
Contact email
Sponsor organisation
GlaxoSmithKline Research and Development Ltd
Eudract number
2016-000507-86
Duration of Study in the UK
2 years, 5 months, 24 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. The purpose of this study is to test how effective daprodustat (a tablet) is compared with darbepoetin alfa (an injection) for the treatment of anaemia associated with CKD in patients who are planning to start or have recently started dialysis, and to see how safely this can be done over a long period of time.
About 300 people in about 15 countries all over the world will take part. Participants and their study doctor will know which treatment they are receiving. The study will last for approximately 1 year.
Documented details/procedures include: medical history, height, weight, blood pressure, heart rate, blood tests, electrocardiogram (ECG), ultrasound, questionnaires, changes to medicines and details of any adverse events.
Study visits are every 2 weeks for the first two months and then every 4 weeks thereafter. 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
17/WM/0041
Date of REC Opinion
18 Apr 2017
REC opinion
Further Information Favourable Opinion