ASCEND-TD: Daprodustat in haemodialysis patients with anaemia of CKD
Research type
Research Study
Full title
A Phase 3 randomised, double-blind, active-controlled, parallel-group, multi-center study in haemodialysis participants with anaemia of chronic kidney disease to evaluate the efficacy, safety and pharmacokinetics of three-times weekly dosing of daprodustat compared to recombinant human erythropoietin, following a switch from recombinant human erythropoietin or its analogs.
IRAS ID
248048
Contact name
Sapna Shah
Contact email
Eudract number
2017-004372-56
Clinicaltrials.gov Identifier
101291, IND
Duration of Study in the UK
1 years, 10 months, 12 days
Research summary
ASCEND-TD: Daprodustat in haemodialysis patients with anaemia of Chronic Kidney Disease (CKD)
The ASCEND-TD study is funded by GSK and will evaluate daprodustat, an experimental medicine for the treatment of anaemia caused by CKD, in adult participants having haemodialysis.
Anaemia develops when blood doesn’t contain enough red blood cells and lacks haemoglobin (an iron rich protein that carries oxygen around the body). Anaemia is common in CKD because the kidneys play a vital role in the production of red blood cells by producing a hormone called erythropoietin. Current treatments for anaemia in CKD consist of iron therapy, blood transfusion or medicines that stimulate the production of red blood cells.The goals of this study are to evaluate the safety and effectiveness of daprodustat treatment given three times a week, compared to epoetin alfa, a medicine which is already approved to treat anaemia caused by CKD. Daprodustat is being tested to see if it safely increases red blood cell production.
Approximately 10 participants ≥18years will take part in the UK. Participants will receive either daprodustat or epoetin alfa. Daprodustat is a pill taken by mouth and epoetin alfa is an injection that is given in the dialysis line. Two thirds of participants will receive daprodustat and one third of participants will receive epoetin alfa. Neither the study team nor the participants will know which study treatment they have received.
Study participants will spend approximately 14 months in the study. A 4-week screening period is followed by a 52-week treatment period and a 4-week follow up period. There will be about 19 study visits for participants to attend and these will be planned for the same days as their dialysis sessions. Participants will undergo various tests and examinations including blood tests, vital signs, ECG, ultrasound and will be asked to complete questionnaires.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1110
Date of REC Opinion
19 Jul 2018
REC opinion
Further Information Favourable Opinion