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RecruitingNot ApplicableNCT07074951

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

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

Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

240 participants

Start Date

Mar 10, 2013

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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

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Interventions

DRUGImmunosuppressive 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.

PROCEDURETonsillectomy

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.

Locations(2)

Research Institute of Nephrology (Pavlov Medical University)

Saint Petersburg, Russia

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia

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NCT07074951