205270 (ASCEND-NHQ)
Research type
Research Study
Full title
A 28-week, randomised, double-blind, placebo-controlled, parallel-group, multi-center, study in recombinant human erythropoietin (rhEPO) naïve non-dialysis participants with anaemia associated with chronic kidney disease to evaluate the efficacy, safety and effects on quality of life of daprodustat compared to placebo. Short Title: Anaemia Studies in CKD: Erythropoiesis via a Novel Prolyl Hydroxylase Inhibitor Daprodustat in Non-Dialysis participants evaluating Haemoglobin and Quality of life (ASCEND-NHQ)
IRAS ID
235555
Contact name
Ashraf Mikhail
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2017-002270-39
Clinicaltrials.gov Identifier
101291, IND
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Summary of Research
The ASCEND-NHQ study is funded by GSK and will evaluate daprodustat, an experimental medicine for the treatment of anaemia caused by chronic kidney disease (CKD), in adult participants who have not undergone dialysis and who have not previously had anaemia treatment (other than iron).
Anaemia develops when blood does not 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 safety, effectiveness and quality of life with daprodustat treatment compared to placebo (a dummy medicine that looks like the study medicine but is not active). The medicine is being tested to see if it safely increases red blood cell production. Daprodustat is being developed as an oral once daily tablet.
Approximately 40 subjects will take part in the UK. Subjects will be randomly assigned 1:1 to take either daprodustat or placebo. Neither the Investigators nor the subjects will know which study treatment they have received.
Study participants will spend approximately 36 weeks in the study. A 4-week screening period is followed by a 28-week treatment period and a 4-week follow up period. Participants will attend 12 visits and undergo various tests and examinations including blood tests, vital signs, ECG, Ultrasound and will be asked to complete questionnaires.Summary of Results
Chronic kidney disease (CKD) is a long-term disease of the kidneys. Some people with CKD cannot make enough red blood cells, which contain an oxygen-carrying protein called haemoglobin (Hgb). This condition is called anaemia due to CKD. Patients with anaemia may be treated with medicines that trigger the body to make more red blood cells, which leads to an increase in Hgb levels. Daprodustat is a medicine that is being tested to treat anaemia due to CKD. Researchers wanted to see how well daprodustat works in improving Hgb levels in participants with anaemia due to CKD. Researchers also assessed the safety of this medicine. The main objective was to compare daprodustat with placebo in improving participants’ Hgb levels during Week 24 to Week 28 (testing period) of the study. Study doctors collected blood samples from the participants. They measured each participant’s Hgb levels on Day 1 (baseline) and during the testing period. The difference in the participant’s baseline Hgb value and the average Hgb value during the testing period was calculated. Researchers concluded that daprodustat improved the Hgb levels in participants with anaemia due to CKD. The side effects reported were as expected in patients with anaemia due to CKD.REC name
Wales REC 3
REC reference
18/WA/0002
Date of REC Opinion
6 Feb 2018
REC opinion
Further Information Favourable Opinion