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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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 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.
Research Institute of Nephrology (Pavlov Medical University)
Saint Petersburg, Russia
RECRUITINGSt. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
RECRUITINGProgression
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).
Time frame: 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.
Time frame: 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
Time frame: From date of inclusion until the date of first documented remission, assessed up to 120 months
Partial remission
Partial remission is defined as a decrease in proteinuria by more than 50% in cases with baseline 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)
Time frame: From date of inclusion until the date of first documented partial remission, assessed up to 120 months
Complete remission
Complete remission is defined as daily proteinuria (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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From date of inclusion until the date of first documented complete remission, assessed up to 120 months
Relapses
In subjects with CR, relapse is defined as the recurrence of proteinuria \>1g/day and haematuria (URBC\>5/HPF) and, in those with PR, as the increase in proteinuria and haematuria \>50% compared to their levels at the time of remission.
Time frame: From date of inclusion until the date of first documented relapse, assessed up to 120 months
The change in proteinuria
Change from baseline in proteinuria
Time frame: Through study completion, an average of 120 months
The change in eGFR
Change from baseline in eGFR by CKD-EPI equation
Time frame: Through study completion, an average of 120 months
Adverse events per 100 patient-years
This rate will be expressed as number of adverse events (AEs) per 100 patient-years of observation in every study group. AE grades are based on the NCI Common Terminology Criteria for Adverse Events version 5.0. Serious adverse events (SAEs) are defined according to FDA recommendations.
Time frame: From date of inclusion until the date of first documented AE, assessed up to 120 months