Comprehensive Cohort of Anemia in Chronic Kidney Disease (CoCoA-CKD)
Research type
Research Study
Full title
A Prospective, Observational, Basket, Comprehensive Cohort Study of Children and Adolescents Aged Less Than 18 Years with Anemia Associated with Chronic Kidney Disease Requiring or Not Requiring Dialysis.
IRAS ID
314048
Contact name
Alex West
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Duration of Study in the UK
4 years, 4 months, 15 days
Research summary
This research study is done to learn more about how anaemia associated with chronic kidney disease (CKD) is managed in children and adolescents.
The study is “observational,” meaning that it collects information only. During the study, participants will continue the normal treatment with their GP. No experimental treatment will be given.
Two groups of people with anaemia associated with CKD can participate in this study. One group is made up of participants who does not need dialysis and another group is made up of participants who are treated with dialysis.
The study is divided into 2 periods: a screening period and the study period. Participants will need to visit the clinic up to 16 times over a period of up to 3 years. Most visits will last up to 30 minutes.
As part of the usual care, participants will be asked questions about their health, how they are feeling and what medicines they are taking.
Routine blood test results can be used for the study. Participants may have blood taken at study visits if routine blood samples were not taken within 2 weeks of screening or within 4 weeks of study visits.
This study will include about 234 participants, aged less than 18 years.
This study forms part of a pair of studies. The other study (ASCEND-P) will be testing a new anaemia treatment called daprodustat (daprodustat is a medicine taken by mouth). If participants take part in this study, they will also be offered participation in the daprodustat study once their age group and kidney function stage begin enrolment. They will be asked to sign a separate informed consent form for the daprodustat study. Participation in the daprodustat study is optional. However, they can only be chosen for the daprodustat study if they participate in this study.REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/PR/1177
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion