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Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT07074951•St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Research Institute of Nephrology (Pavlov Medical University)

Saint Petersburg, Russia

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia

Key Dates

Start Date

March 10, 2013

Primary Completion Date

March 10, 2026

Completion Date

December 10, 2027

Last Updated

July 20, 2025

Enrollment

240

ESTIMATED participants

Conditions

Primary IgA-nephropathyHigh-riskCaucasians

Interventions

Immunosuppressive treatment

DRUG

Tonsillectomy

PROCEDURE

Contacts

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

CONTACT

(812)338-69-01 dobronravov@nephrolog.ru

Zinaida Kochoyan, Nephrologist

CONTACT

(812)338-69-21 zinshak@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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