Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunosuppression combined with tonsillectomy (IST+TE group) | Experimental | Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120). |
|
| Control group (Active comparator): IST without TE (IST group) | Other | Сontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunosuppressive treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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 | From date of inclusion until the date of first documented remission, assessed up to 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From date of inclusion until the date of first documented partial remission, assessed up to 120 months |
Not provided
Inclusion Criteria:
Primary IgA-nephropathy (IgAN) patients with:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Dobronravov, Professor, MD, PhD, DMedSci | Contact | (812)338-69-01 | dobronravov@nephrolog.ru | |
| Zinaida Kochoyan, Nephrologist | Contact | (812)338-69-21 | zinshak@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Dobronravov, Professor, MD, PhD, DMedSci | St. Petersburg State Pavlov Medical University | Principal Investigator |
| Zinaida Kochoyan, Nephrologist | St. Petersburg State Pavlov Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Nephrology (Pavlov Medical University) | Recruiting | Saint Petersburg | 197022 | Russia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30980653 | Background | Barbour SJ, Coppo R, Zhang H, Liu ZH, Suzuki Y, Matsuzaki K, Katafuchi R, Er L, Espino-Hernandez G, Kim SJ, Reich HN, Feehally J, Cattran DC; International IgA Nephropathy Network. Evaluating a New International Risk-Prediction Tool in IgA Nephropathy. JAMA Intern Med. 2019 Jul 1;179(7):942-952. doi: 10.1001/jamainternmed.2019.0600. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).
Control group includes subjects, fulfilled the same eligibility criteria and underwent only immunosuppression without tonsillectomy in the same time period (the IST group, n=120).
Not provided
Not provided
Not provided
Not provided
|
| Tonsillectomy | Procedure | 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. |
|
| 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. | 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. | 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 | Through study completion, an average of 120 months |
| The change in eGFR | Change from baseline in eGFR by CKD-EPI equation | 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. | From date of inclusion until the date of first documented AE, assessed up to 120 months |
| St. Petersburg State Pavlov Medical University |
| Recruiting |
| Saint Petersburg |
| 197022 |
| Russia |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |