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

St. Petersburg State Pavlov Medical University

Status: Enrolling

Conditions: Caucasians; Primary IgA-nephropathy; High-risk

Treatments: Procedure: Tonsillectomy; Drug: Immunosuppressive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07074951

VD285/IgAN/TE+IST

Details and patient eligibility

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Immunosuppression combined with tonsillectomy (IST+TE group)

Experimental group

Description:

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

Treatment:

Drug: Immunosuppressive treatment

Procedure: Tonsillectomy

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

Other group

Description:

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

Treatment:

Drug: Immunosuppressive treatment