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NCT Number: NCT07074951

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

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.

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Key information

Conditions

Primary IgA-nephropathy Autoimmune Diseases Caucasians Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA High-risk Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology (Pavlov Medical University), Saint Petersburg, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary IgA-nephropathy (IgAN) patients with:

  • DP >1 g with haematuria (>5 RBC/HPF)
  • 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

  • Age <18 or >75 years;
  • eGFR ≤20 ml/min/1.73m2
  • Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP <1.0 g
  • Contraindications to IST or TE
  • Patients with any co-existing kidney disease
  • Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
  • Patients with diabetes mellitus
  • 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
  • Incomplete empiric IST administered prior to kidney biopsy
  • Pregnancy

Treatment and study plan

Immunosuppressive treatment

Drug

Patients will be able to receive the corticosteroid (CS) monotherapy or CS in combination with other immunosuppressive drugs (e.g. cyclophosphamide, mycophenolic acid) by a decision of treating physician.

CS treatment will start with intravenous or oral induction. In the first case, methylprednisolone will be administered intravenously for 1-3 days at the dosage of 500-1000 mg. Oral prednisolone will be initiated at a dose of 0.5 to 1.0 mg/kg body weight, not exceeded 60 mg/day (week 1) with a rapid decrease by 5 mg each subsequent week until a maintenance dose of 5 mg/day will be reached. Patients will receive maintenance dose for 6 to 12 months.

Tonsillectomy

Procedure

Tonsillectomy will be done in accordance with local clinical practice. TE has to be performed no earlier than 12 months before and no later than 12 months after the initiation of IST.

Primary outcomes

  1. Progression

    Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

    The composite end-point of disease progression includes: eGFR decline >40% of baseline level, ESKD (defined as long-term eGFR <15 ml/min/1.73m2 for more than 3 months or need of initiation of renal replacement therapy (RRT).

  2. Overall remission (partial or complete remission)

    Time frame: From date of inclusion until the date of first documented overall remission, assessed up to 120 months

    Partial remission (PR) is defined as a decrease in proteinuria by more than 50% in cases with baseline daily proteinuria (DP) <3.5 g, and in those with DP ≥3.5 g, as its decrease >50% to level <3.5 g/day in combination with regression of hematuria by at least 70% (in 3 consecutive measurements). Complete remission (CR) is defined as DP <0.5 g/day and the disappearance of hematuria (URBC <5/HPF). Any remission is registered in the absence of eGFR decrease >20% from the baseline.

  3. Time to clinical remission

    Time frame: From date of inclusion until the date of first documented remission, assessed up to 120 months

    Cumulative rate of overall (partial or complete) clinical remission

Secondary outcomes

  1. Partial remission

    Time frame: From date of inclusion until the date of first documented partial remission, assessed up to 120 months

    Partial remission is defined as a decrease in proteinuria by more than 50% in cases with baseline DP <3.5 g, and in those with DP ≥3.5 g, as its decrease >50% to level <3.5 g/day in combination with regression of hematuria by at least 70% (in 3 consecutive measurements)

  2. Complete remission

    Time frame: From date of inclusion until the date of first documented complete remission, assessed up to 120 months

    Complete remission is defined as daily proteinuria (DP) <0.5 g/day and the disappearance of hematuria (URBC <5/HPF). Any remission is registered in the absence of eGFR decrease >20% from the baseline.

  3. Relapses

    Time frame: From date of inclusion until the date of first documented relapse, assessed up to 120 months

    In subjects with CR, relapse is defined as the recurrence of proteinuria >1g/day and haematuria (URBC>5/HPF) and, in those with PR, as the increase in proteinuria and haematuria >50% compared to their levels at the time of remission.

  4. The change in proteinuria

    Time frame: Through study completion, an average of 120 months

    Change from baseline in proteinuria

  5. The change in eGFR

    Time frame: Through study completion, an average of 120 months

    Change from baseline in eGFR by CKD-EPI equation

  6. Adverse events per 100 patient-years

    Time frame: From date of inclusion until the date of first documented AE, assessed up to 120 months

    This rate will be expressed as number of adverse events (AEs) per 100 patient-years of observation in every study group. AE grades are based on the NCI Common Terminology Criteria for Adverse Events version 5.0. Serious adverse events (SAEs) are defined according to FDA recommendations.

Study contacts

Contact information is provided by the study sponsor or research team.

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

CONTACT

[email protected]

(812)338-69-01

Zinaida Kochoyan, Nephrologist

CONTACT

[email protected]

(812)338-69-21

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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