SPAR-RWE-EAP-UK
Research type
Research Study
Full title
Real World Experience of IgA Nephropathy Patients Treated with Sparsentan Under an Early Access Program
IRAS ID
348374
Contact name
Chee Kay Cheung
Contact email
Sponsor organisation
CSL Vifor
Clinicaltrials.gov Identifier
64710, CPMS ID
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Immunoglobulin A nephropathy(IgAN) is a kidney disease characterized by the buildup of an antibody(IgA) in the kidneys, leading to inflammation and potential kidney damage. It is the most common form of primary glomerulonephritis and progresses to kidney failure in about one-third of patients within 10-20years.
Standard treatment is rigorous blood pressure control using renin-angiotensin-aldosterone system inhibitor therapy. Additional treatment options are limited - particularly for those at high risk of progression, where guidelines recommend enrolling in clinical trials, highlighting the unmet need.
Sparsentan is a dual-acting angiotensin receptor blocker(ARB) and endothelin type A receptor blocker that has shown promising efficacy and safety in IgAN clinical trials. It received accelerated approval in USA, and recently from EMA/MHRA to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. In several countries, pre-approval, Vifor made sparsentan available free-of-charge for these patients with an Early Access Program(EAP).
The primary goal of an EAP is to provide access to treatment where there is unmet need, but it is also an early opportunity to study how the medicine works in real-world patients.
In this project, collection/analysis of data from medical records is proposed. This could provide early insights into the effectiveness of treatment with sparsentan in NHS clinical practice. These insights compliment randomised controlled trial evidence and will be of interest to the medical community caring for IgAN patients.
Our aim is for historic data from all UK EAP patients to be included, from enrolment until the end of EAP treatment. Medical record data, recorded as care happened, should be enough for analysis without requiring any additional study visits for patients. As an observational project, using only historic data, no change will be made to patient care as part of this research.
Through improving the understanding of effectiveness and safety during sparsentan treatment, this project will support future patient care.
REC name
London - Queen Square Research Ethics Committee
REC reference
25/PR/0415
Date of REC Opinion
2 Jun 2025
REC opinion
Further Information Favourable Opinion