Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSt. Petersburg State Pavlov Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immunosuppressive treatment
DrugPatients 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
Procedure/SurgeryTonsillectomy 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Immunosuppression combined with tonsillectomy (IST+TE group)Experimental treatment 2 interventions
Group B: Control group (Active comparator): IST without TE (IST group)Other 1 intervention
Trial outcomes
Primary outcomes
1
Progression
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 months2
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 months3
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 monthsSecondary outcomes
1
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 months2
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.
Time frame
From date of inclusion until the date of first documented complete remission, assessed up to 120 months3
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 months4
The change in proteinuria
Change from baseline in proteinuria
Time frame
Through study completion, an average of 120 monthsSponsors and contacts
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Source ClinicalTrials.gov