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

Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)

This trial will see if removing the tonsils combined with immunosuppressive medicine helps Caucasian adults with high-risk IgA nephropathy preserve kidney function and reduce proteinuria.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: St. Petersburg State Pavlov Medical University (Academic / other)
• Locations: 2 sites (Saint Petersburg and 1 other locations)
• Trial ID: NCT07074951 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 years old of Caucasian background with primary IgA nephropathy who have significant proteinuria with hematuria or lower proteinuria but a >11% five-year dialysis risk plus specific active histologic lesions are the intended candidates.

Not a fit: Patients with very low kidney function (eGFR ≤20 ml/min/1.73 m2), mild biopsy lesions, secondary forms of IgA nephropathy, diabetes, or contraindications to surgery or immunosuppression are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If effective, the combined tonsillectomy and immunosuppression approach could slow disease progression and reduce the chance of needing dialysis in high-risk Caucasian patients.

How similar studies have performed: Prior reports, mainly from East Asian cohorts, have suggested benefit of tonsillectomy plus immunosuppression in some patients with IgA nephropathy, but results are mixed and evidence in Caucasian populations remains limited.

Eligibility criteria

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 this trial is running

Saint Petersburg and 1 other locations

• 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

Conditions Primary IgA-nephropathy; High-risk; Caucasians; Corticosteroids; Tonsillectomy; Progression; Remission