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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
month 12 from diagnosis

Secondary outcomes

1

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

Time frame
month 6 from diagnosis
2

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

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

Time frame
month 24 from diagnosis
3

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

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

Time frame
At the end of follow-up, that is at least 2 years from inclusion
4

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

Major Adverse Renal Events will be defined as the occurrence of any of the following events at the time of assessment: * Renal failure, defined as a loss of more than 40% in eGFR as compared to the initial eGFR or eGFR \<15 ml/min/1.73m2 * Dialysis * Transplantation

Time frame
month 12 from diagnosis

Other outcomes

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