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

RecruitingNAAges 18 Years - 75 YearsAllSt. Petersburg State Pavlov Medical University
NCT07074951 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Immunosuppressive treatment
  • Tonsillectomy
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Where

2 sites
Research Institute of Nephrology (Pavlov Medical University)
Saint Petersburg, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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