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Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy

Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy

Recruiting
18-75 years
All
Phase N/A

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Overview

The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.

Eligibility

Inclusion Criteria:

Primary IgA-nephropathy (IgAN) patients with:

  1. DP >1 g with haematuria (>5 RBC/HPF)
  2. DP <1 g with haematuria AND probability of starting dialysis within 5 years >11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents

Exclusion Criteria:

  1. Age <18 or >75 years;
  2. eGFR ≤20 ml/min/1.73m2
  3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP <1.0 g
  4. Contraindications to IST or TE
  5. Patients with any co-existing kidney disease
  6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
  7. Patients with diabetes mellitus
  8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids
  9. Incomplete empiric IST administered prior to kidney biopsy
  10. Pregnancy

Study details
    Primary IgA-nephropathy
    High-risk
    Caucasians

NCT07074951

St. Petersburg State Pavlov Medical University

15 October 2025

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