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

Recruiting now · Not applicable

Conditions studied: Primary IgA-nephropathy, High-risk, Caucasians

In brief

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.

Key facts

Study ID

NCT07074951

Run by

St. Petersburg State Pavlov Medical University

People needed

240

Starts

2013-03-10

Expected to finish

2027-12-10

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary IgA-nephropathy (IgAN) patients with:
• DP >1 g with haematuria (>5 RBC/HPF)
• 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

You may not qualify if…

• Age <18 or >75 years;
• eGFR ≤20 ml/min/1.73m2
• Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP <1.0 g
• Contraindications to IST or TE
• Patients with any co-existing kidney disease
• Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
• Patients with diabetes mellitus
• 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
• Incomplete empiric IST administered prior to kidney biopsy
• Pregnancy

Where it is running

• Research Institute of Nephrology (Pavlov Medical University) — Saint Petersburg, Russia (enrolling)
• St. Petersburg State Pavlov Medical University — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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