FSGS Natural History Study
Research type
Research Study
Full title
A Natural History Study of Patients With Biopsy-proven Focal Segmental Glomerulosclerosis and Nephrotic Range Proteinuria Who Are of Recent African Ancestry or Have 2 APOL1 Risk Alleles
IRAS ID
280214
Contact name
Alex Mutebi
Contact email
Sponsor organisation
Vertex Pharmaceuticals
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This is a retrospective, noninterventional natural history study of patients with biopsy-proven focal segmental glomerulosclerosis (FSGS) and nephrotic range proteinuria who are either of recent African ancestry (defined as identified or self-identified as Black, Caribbean, African American, or Sub-Saharan African) or have 2 APOL1 risk alleles. Data collection will be carried out via chart review at participating sites.
The study's primary objective is to assess the proportion of FSGS patients who achieve spontaneous remission, defined as remission while not receiving treatment with corticosteroids or any other immunosuppressive therapy.
Patient charts to be included in the study will be selected according to the protocol-defined eligibility criteria (i.e., inclusion/exclusion criteria focused on identifying and excluding patients with various other/secondary causes of FSGS); as part of the screening process, each patient's diagnosis of FSGS will be confirmed by an independent pathologist. Data on each patient will be collected starting ≤6 months before the kidney biopsy that led to the patient’s FSGS diagnosis up until the end of available follow-up (i.e., date of the chart review, date of mortality, documented end-stage kidney disease, or loss to follow-up). The maximum duration of follow-up (retrospectively observed) will be 60 months after the kidney biopsy. All patients included must have received a kidney biopsy between January 2008 and December 2018.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/1025
Date of REC Opinion
26 Oct 2020
REC opinion
Further Information Favourable Opinion