An interventional study of Immunosuppressive treatment and Tonsillectomy in Primary IgA-nephropathy, High-risk and Caucasians, sponsored by St. Petersburg State Pavlov Medical University. Recruiting at 2 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by St. Petersburg State Pavlov Medical University · Not applicable, Interventional, and Treatment
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.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 240 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Primary IgA-nephropathy (IgAN) patients with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).
Drug: Immunosuppressive treatment · Procedure: Tonsillectomy
Сontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period.
Drug: 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 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.
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 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.
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
Plan to share: No
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St. Petersburg State Pavlov Medical University