The esCapEKD cohort study prospective study of children with CKD
Research type
Research Study
Full title
Prospective Cohort Study of Children with Chronic Kidney Disease, The esCapeKD Cohort Study
IRAS ID
347980
Contact name
Franz Schaefer
Contact email
Sponsor organisation
University of Heidelberg
Duration of Study in the UK
5 years, 9 months, 7 days
Research summary
The esCapeKD Cohort Study aims to provide comprehensive real-world information about the natural history of pediatric chronic kidney disease (CKD) and its consequences in pediatric patients receiving the current standard of care. The study also seeks to facilitate the identification and access of suitable patients to clinical trials on innovative therapies and promote research into novel risk markers of CKD progression in children.
An important secondary objective of the study is the harmonization and optimization of treatment outcomes by continuously monitoring and benchmarking CKD-specific key performance indicators (KPIs). The study design involves a long-term observational, non-interventional, multinational cohort study conducted as a collaboration of the ESCAPE Clinical Research Network and the European Rare Kidney Disease Reference Network.
Pseudonymized clinical data will be collected through the European Rare Kidney Disease Registry and will include disease-specific information on kidney function, comorbidities, pharmacological treatment, and quality of care. Biospecimens (DNA, plasma, serum, and urine) will be collected annually on the occasion of routine clinical visits, and patients will be followed until the attainment of end-stage kidney disease (ESKD) or adulthood.
The study anticipates the discovery of new biomarkers and the development of algorithms to quantify disease progression risk, which will inform the future management of patients with CKD and potentially impact the treatment of study participants. Additionally, the planned monitoring of key performance indicators aims to optimize CKD management, with potential long-term health benefits for participating patients.
No formal sample size was calculated for this registry study, and it is planned to include all eligible patients willing to participate. The study expects to enroll around 600 prevalent patients worldwide, with an average of 25 patients per center, and include 50-100 incident patients each year, with inclusion to be stopped when 1,000 CKD patients have been enrolled.
In summary, the esCapeKD Cohort Study is a vital effort to gather real-world data on pediatric CKD, optimize treatment outcomes, and potentially improve the future management and care of patients with this condition.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0135
Date of REC Opinion
4 Jun 2025
REC opinion
Further Information Favourable Opinion