Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07074951

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

Led by St. Petersburg State Pavlov Medical University · Updated on 2025-07-20

240

Participants Needed

2

Research Sites

769 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary IgA-nephropathy patients with proteinuria greater than 1 gram and hematuria (more than 5 red blood cells per high power field)
  • Primary IgA-nephropathy patients with proteinuria less than 1 gram and hematuria who have a greater than 11% probability of starting dialysis within 5 years and at least one histologic change such as mesangial proliferation, endocapillary hypercellularity, or cellular crescents
  • Caucasian ethnicity
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Age under 18 or over 75 years
  • Estimated glomerular filtration rate (eGFR) less than or equal to 20 ml/min/1.73m2
  • Mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, or proteinuria less than 1.0 gram
  • Contraindications to immunosuppressive treatment or tonsillectomy
  • Presence of any co-existing kidney disease
  • Secondary IgA-nephropathy (such as Schoenlein-Henoch purpura or liver cirrhosis)
  • Diabetes mellitus
  • Any significant acute illness within 60 days before kidney biopsy, including infection, aseptic bone necrosis, myocardial infarction, or cerebrovascular stroke
  • Incomplete empiric immunosuppressive treatment before kidney biopsy
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Research Institute of Nephrology (Pavlov Medical University)

Saint Petersburg, Russia, 197022

Actively Recruiting

2

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia, 197022

Actively Recruiting

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Research Team

V

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

CONTACT

Z

Zinaida Kochoyan, Nephrologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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