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

NCT07074951 | Recruiting DMC

• 1 other identifier: VD285/IgAN/TE+IST
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary IgA-nephropathy; High-risk; Caucasians

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Progression

  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).

  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

• Overall remission (partial or complete remission)

  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.

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

• Time to clinical remission

  Cumulative rate of overall (partial or complete) clinical remission

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

Secondary Outcomes (6)

• Partial remission

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

• Complete remission

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

• Relapses

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

• The change in proteinuria

  Through study completion, an average of 120 months

• The change in eGFR

  Through study completion, an average of 120 months

Study Arms (2)

Immunosuppression combined with tonsillectomy (IST+TE group)

EXPERIMENTAL

Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).

Drug: Immunosuppressive treatment; Procedure: Tonsillectomy

Control group (Active comparator): IST without TE (IST group)

OTHER

Сontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period.

Drug: Immunosuppressive treatment

Interventions

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.

Control group (Active comparator): IST without TE (IST group); Immunosuppression combined with tonsillectomy (IST+TE group)

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.

Immunosuppression combined with tonsillectomy (IST+TE group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (2)

Research Institute of Nephrology (Pavlov Medical University)

Saint Petersburg, 197022, Russia

RECRUITING

St. Petersburg State Pavlov Medical University

Saint Petersburg, 197022, Russia

RECRUITING

Related Publications (1)

• Barbour SJ, Coppo R, Zhang H, Liu ZH, Suzuki Y, Matsuzaki K, Katafuchi R, Er L, Espino-Hernandez G, Kim SJ, Reich HN, Feehally J, Cattran DC; International IgA Nephropathy Network. Evaluating a New International Risk-Prediction Tool in IgA Nephropathy. JAMA Intern Med. 2019 Jul 1;179(7):942-952. doi: 10.1001/jamainternmed.2019.0600.

  PMID: 30980653 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA; Disease Progression

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Vladimir Dobronravov, Professor, MD, PhD, DMedSci

  St. Petersburg State Pavlov Medical University

  PRINCIPAL INVESTIGATOR

• Zinaida Kochoyan, Nephrologist

  St. Petersburg State Pavlov Medical University

  STUDY CHAIR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director for science RM Gorbacheva Institute

Model Details: Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120). Control group includes subjects, fulfilled the same eligibility criteria and underwent only immunosuppression without tonsillectomy in the same time period (the IST group, n=120).

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 20, 2025
• Study Start: March 10, 2013
• Primary Completion: March 10, 2026
• Study Completion (Estimated): December 10, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)