RESistance of IgA Nephropathy to Conventional and Newly-approved Therapies: an Observational, Real-life Study (RESIGAN)

NCT06926244 | Recruiting

• 1 other identifier: APHP 240615
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. The prognosis varies significantly, from benign hematuria to rapidly progressive glomerulonephritis, potentially leading to end-stage renal disease within months. The MEST-C classification enhances prognosis characterization and informs integrated scoring systems; however, while useful for assessing overall prognosis, these scores do not reliably predict treatment responses and are unvalidated for IgA vasculitis nephritis. Given the disease's heterogeneity, treatment options for IgAN, with or without vasculitis, are controversial. Nephroprotective strategies that lower intraglomerular pressure through RAS blockade are essential in managing IgAN. Steroids are considered for rapidly progressive cases, yet their effectiveness in persistent proteinuria despite optimized nephroprotection is debated. Other immunosuppressive therapies, such as B cell targeting and complement inhibition, are under investigation. Recently developed nephroprotective strategies, including SGLT2 inhibitors and endothelin-1 receptor antagonists, may significantly influence future therapeutic approaches. Although available in many European countries, their real-world effectiveness has not been evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized nephroprotection is a critical unmet need. We hypothesize that innovative nephroprotective strategies will reduce the risk of persistent proteinuria and renal dysfunction in an IgAN cohort.

Conditions

IgA Nephropathy (IgAN)

Keywords

IgAN; Primary Glomerulonephritis; Mesangial IgA Deposits

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twelve months from diagnosis.

  Persistent proteinuria is defined as protein/creatinine ratio \>1 g/g; renal dysfunction is defined as a loss of \>20% eGFR (Estimated Glomerular Filtration Rate) as compared to eGFR measured at baseline.

  month 12 from diagnosis

Secondary Outcomes (9)

• Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at 6 months from diagnosis

  month 6 from diagnosis

• Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twenty-four months from diagnosis.

  month 24 from diagnosis

• Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at the end of follow-up.

  At the end of follow-up, that is at least 2 years from inclusion

• Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 12, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure

  month 12 from diagnosis

• Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 6, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure

  month 6 from diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 800 patients is expected: * Retrospective cohort: 600 patients to be expected : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from 2017 to date of start of the study * Prospective cohort: 200 participants : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from the date of start of the study : 1 to 2patients with new diagnosis/ site/month

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Nephrology department, Hospital Pitié - Salpêtrière (ASSISTANCE PUBLIQUE HOPITAUX DE PARIS AP-HP)

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Khalil EL KAROUI, PhD

CONTACT

+33 1 56 01 63 17; khalil.el-karoui@aphp.fr

Sarra POCHON, MD

CONTACT

+33 1 42 16 75 74; sarra.pochon@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 13, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

FR (1)