Tonsil removal plus immunosuppression for high-risk IgA nephropathy in Caucasian adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, prospective, non-randomised controlled protocol testing a combined approach of tonsillectomy and systemic immunosuppressive therapy in Caucasian patients judged to be at high risk of progressive IgA nephropathy. Eligible patients have either substantial proteinuria with hematuria or lower proteinuria but a predicted >11% five-year dialysis risk plus specific biopsy features such as mesangial proliferation, endocapillary hypercellularity, or cellular crescents. Patients with very low eGFR, diabetes, secondary IgAN, other kidney diseases, or recent significant acute illness are excluded. Outcomes will compare kidney function and proteinuria over follow-up between those receiving the combined intervention and contemporaneous controls receiving standard care.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Vladimir Dobronravov, Professor, MD, PhD, DMedSci — St. Petersburg State Pavlov Medical University
• Study coordinator: Vladimir Dobronravov, Professor, MD, PhD, DMedSci
• Email: dobronravov@nephrolog.ru
• Phone: (812)338-69-01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.