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Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
Sponsor: St. Petersburg State Pavlov Medical University
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.
Official title: Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2013-03-10
Completion Date
2027-12-10
Last Updated
2025-07-20
Healthy Volunteers
No
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.
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.
Locations (2)
Research Institute of Nephrology (Pavlov Medical University)
Saint Petersburg, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia