NEPHROTARGET
Research type
Research Study
Full title
ASSESSING TREAT-TO-TARGET FEASIBILITY AND BIOMARKER MONITORING IN CHILDHOOD SYSTEMIC LUPUS ERYTHEMATOSUS: THE NEPHROTARGET STUDY
IRAS ID
345553
Contact name
Eve Smith
Contact email
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The NEPHROTARGET study aims to explore an internationally recommended approach for treating children with lupus (cSLE) called "Treat-to-Target" (T2T). This study will implement T2T, where treatment is continuously adjusted to reach and maintain specific health targets. Once a target is achieved, efforts will aim for a more stringent target or maintain the current one, with further treatment optimisation if control is lost. The study will also assess if urine biomarkers and nailfold capillaroscopy can improve the T2T approach. This study will help us understand how to implement this approach practically across two centres with different T2T experience levels. By evaluating the feasibility of T2T, we aim to develop best practices and facilitate future multicentre studies to assess T2T effectiveness.
Main aims:
• Assess the feasibility of implementing the T2T in two centres.• Investigate whether urine biomarkers and nailfold capillaroscopy can improve the accuracy of this approach.
• Understand the experiences of patients, families, and clinicians with the T2T approach.
Methods:
• cSLE patients will have clinic visits every 6-12 weeks depending on whether their disease is adequately controlled (defined being in target).
• At each visit, disease activity will be assessed, and urine samples will be collected.
• A specialised panel of urine biomarkers, which has shown promise in identifying active kidney disease, will be measured at the end of the study.Optional embedded studies:
• Nailfold capillaroscopy, a non-invasive test examining small blood vessels in the fingers, will be conducted to see if it provides additional information about diseaes activity.
• Qualitative interviews will be conducted with patients, families, and clinicians to gather insights on the T2T approach's acceptability, and any challenges faced.Impact:
This study will help to refine the T2T approach and develop better tools for monitoring cSLE. Insights gained will guide future, larger-scale clinical studies and could significantly enhance care for cSLE.REC name
North of Scotland Research Ethics Committee 2
REC reference
24/NS/0103
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion