ASCEND-P
Research type
Research Study
Full title
An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis.
IRAS ID
1005300
Contact name
Alex West
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-002013-34
Research summary
This research study is being done to learn more about anaemia associated with CKD (Chronic Kidney Disease) and related conditions and if a study medicine called daprodustat can improve anaemia associated with CKD in children and adolescents.
All participants will receive daprodustat for a total of 52 weeks and will be followed for an additional 4 weeks after completing treatment. Daprodustat is a medicine given by mouth in this study and is used instead of the usual anaemia treatment, commonly called erythropoietin or EPO, which is given as an injection.
This research study is done by GlaxoSmithKline (also called “GSK”), a pharmaceutical company.
Two groups of people with anaemia associated with CKD can participate in this study. One group is made up of participants who do not need dialysis and another group is made up of participants who are treated with dialysis.
This study is considered “open-label,” which means participants, and everyone involved with the study will know what dose of daprodustat is given.
The study is divided into 3 time periods: a screening period, a treatment period, and a follow-up period. Participants will need to visit the hospital at least 14 times over a period of about 1 year. Most visits will last up to 2 hours.
As part of the usual care, participants will be asked questions about their health, how they are feeling and what medicines they are taking.
Participants should attend all study visits and comply with all the scheduled procedures and activities during the study.
All participants who are approached for this study will already be participating in the prospective observational Cohort Study 212914, also running at the same trial sites.
This study will include about 120 participants (children and adolescents), aged 3 months to under 18 years and will last for 13 months (1 year and 1 month).REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0132
Date of REC Opinion
10 Nov 2022
REC opinion
Further Information Favourable Opinion