Why some cases of IgA nephropathy resist conventional and new therapies: a real-life observational look
RESistance of IgA Nephropathy to Conventional and Newly-approved Therapies: an Observational, Real-life Study (RESIGAN)
This project will collect real-world data from adults with biopsy-proven IgA nephropathy to see which patients keep having proteinuria or kidney decline despite modern nephroprotective measures and newer treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06926244 on ClinicalTrials.gov |
What this trial studies
This is an observational, real-world registry enrolling adults (≥18) with renal biopsy–confirmed IgA nephropathy diagnosed since 2017 and who consent to use of their clinical data. Clinicians will record baseline biopsy features including MEST-C, treatments received (RAS blockade, SGLT2 inhibitors, endothelin-1 antagonists, steroids, and other immunomodulators), and longitudinal outcomes such as persistent proteinuria and renal function change. The study will analyze which clinical, histologic, and treatment factors are associated with treatment resistance and progressive kidney dysfunction. No investigational drugs are given; the goal is to describe real-life treatment patterns and predictors of poor response to currently available therapies.
Who should consider this trial
Good fit: Adults (age ≥18) with a renal biopsy after 2017 showing IgA deposits consistent with IgA nephropathy who agree to use of their clinical data.
Not a fit: Children, patients without a biopsy-confirmed diagnosis or with biopsies dated before 2017, and those who do not consent to data use would not be eligible and therefore would not benefit from this registry's findings.
Why it matters
Potential benefit: If successful, the project could help identify which patients are likely to resist current therapies and guide more personalized treatment and follow-up strategies.
How similar studies have performed: Some randomized trials (for example with SGLT2 inhibitors) have shown kidney-protective effects including in IgAN subgroups, but using a real-world registry tied to histology to identify predictors of treatment resistance is relatively novel and not yet validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient: age ≥ 18 years * Renal biopsy performed after 2017 showing IgA deposits leading to the diagnosis of IgAN (the date of diagnosis being the index date) * Informed patient and who does not object to the use of his data Exclusion Criteria: \- None
Where this trial is running
Paris
- Nephrology department, Hospital Pitié - Salpêtrière (ASSISTANCE PUBLIQUE HOPITAUX DE PARIS AP-HP) — Paris, France (Recruiting)
Study contacts
- Study coordinator: Khalil EL KAROUI, PhD
- Email: khalil.el-karoui@aphp.fr
- Phone: +33 1 56 01 63 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.