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

NCT ID: NCT07074951

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-10
• Study Completion Date: 2027-12-10

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunosuppression combined with tonsillectomy (IST+TE group)

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

Group Type: EXPERIMENTAL

Immunosuppressive treatment

Intervention Type: 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

Intervention Type: 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.

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

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

Group Type: OTHER

Immunosuppressive treatment

Intervention Type: 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.

Interventions

Immunosuppressive treatment

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.

Intervention Type: DRUG

Tonsillectomy

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Vice-director for science RM Gorbacheva Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

Role: PRINCIPAL_INVESTIGATOR

St. Petersburg State Pavlov Medical University

Zinaida Kochoyan, Nephrologist

Role: STUDY_CHAIR

St. Petersburg State Pavlov Medical University

Locations

Research Institute of Nephrology (Pavlov Medical University)

Saint Petersburg, , Russia

Site Status: RECRUITING

St. Petersburg State Pavlov Medical University

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

Role: CONTACT

dobronravov@nephrolog.ru

(812)338-69-01

Zinaida Kochoyan, Nephrologist

Role: CONTACT

zinshak@gmail.com

(812)338-69-21

Facility Contacts

Vladimir Dobronravov, Professor, MD, PhD, DMedSci

Role: primary

dobronravov@nephrolog.ru

(812)338-69-01

References

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.

Reference Type: BACKGROUND

PMID: 30980653 (View on PubMed)

Other Identifiers

VD285/IgAN/TE+IST

Identifier Type: -

Identifier Source: org_study_id