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

Launched by ST. PETERSBURG STATE PAVLOV MEDICAL UNIVERSITY · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of treatments—removing the tonsils (tonsillectomy) and using medicines that suppress the immune system—can help people with a kidney condition called IgA-nephropathy (IgAN) who are at high risk of kidney damage. IgA-nephropathy is a disease where the immune system causes inflammation in the kidneys, which can lead to kidney problems over time. This study focuses on Caucasian adults who have signs of active kidney disease, such as blood in the urine and protein loss, and who are more likely to need dialysis (a treatment for kidney failure) within the next five years.

To join this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of primary IgA-nephropathy with specific signs of kidney damage. People with mild kidney problems, other kidney diseases, diabetes, or recent serious illnesses are not eligible. If accepted, participants will receive both tonsil removal surgery and immune-suppressing medication to see if this combined approach works better than standard care. The study is currently recruiting patients, and those interested should discuss with their doctor whether this trial might be a good option for their treatment.

Gender

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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