Primary IgA-nephropathyNCT07074951
Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
A study testing Immunosuppressive treatment and Tonsillectomy in people with Primary IgA-nephropathy and High-risk, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary IgA-nephropathy, High-risk, Caucasians
- What is being tested?
- Immunosuppressive treatment and Tonsillectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Mar 2013to 10 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary IgA-nephropathy (IgAN) patients with:
- 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
Who cannot join
- 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
- Patients with any co-existing kidney disease
- Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
Show all 10Show fewer
- Patients with diabetes mellitus
- Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids
- Incomplete empiric IST administered prior to kidney biopsy
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Research Institute of Nephrology (Pavlov Medical University)
Saint Petersburg, 197022
- Recruiting
St. Petersburg State Pavlov Medical University
Saint Petersburg, 197022
Vladimir Dobronravov, Professor, MD, PhD, DMedSci, (812)338-69-01, dobronravov@nephrolog.ru
About this study
Official title: Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)
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.
- Conditions
- Primary IgA-nephropathy, High-risk, Caucasians
- Being tested
- Immunosuppressive treatment, Tonsillectomy
- Keywords
- Primary IgA-nephropathy, Corticosteroids, Tonsillectomy, High-risk, Caucasians, Progression, Remission
- Medical subject headings
- Glomerulonephritis, IGA, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive treatmentDrug
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.
TonsillectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Immunosuppressive treatment; Procedure: Tonsillectomy |
| 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. Receives: Drug: Immunosuppressive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: From date of inclusion until the date of first documented remission, assessed up to 120 months
Secondary outcomes (6)
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 120 months
The change in eGFR
Change from baseline in eGFR by CKD-EPI equation
Measured: 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.
Measured: From date of inclusion until the date of first documented AE, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Mar 2013
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary IgA-nephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Vladimir Dobronravov, Professor, MD, PhD, DMedSci, Principal investigator, St. Petersburg State Pavlov Medical UniversityZinaida Kochoyan, Nephrologist, Study chair, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074951
- Sponsor's protocol ID
- VD285/IgAN/TE+IST
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30980653
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)
- ClinicalTrials.gov ID
- NCT07074951
- Acronym / sponsor ID
- VD285/IgAN/TE+IST
- Conditions
- Primary IgA-nephropathy, High-risk, Caucasians
- Keywords
- Primary IgA-nephropathy, Corticosteroids, Tonsillectomy, High-risk, Caucasians, Progression, Remission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2013 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression combined with tonsillectomy (IST+TE group) | Experimental | Drug: Immunosuppressive treatment, Procedure: TonsillectomyExperimental 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 | Drug: Immunosuppressive treatmentСontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Patients with any co-existing kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppressive treatmentPatients 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. | Drug | Control group (Active comparator): IST without TE (IST group), Immunosuppression combined with tonsillectomy (IST+TE group) |
| TonsillectomyTonsillectomy 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. | Procedure or surgery | Immunosuppression combined with tonsillectomy (IST+TE group) |
Primary outcome
Progression
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
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).
Overall remission (partial or complete remission)
Time frame: From date of inclusion until the date of first documented overall remission, assessed up to 120 months
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 to clinical remission
Time frame: From date of inclusion until the date of first documented remission, assessed up to 120 months
Cumulative rate of overall (partial or complete) clinical remission
6 secondary outcomes
Partial remission
Time frame: From date of inclusion until the date of first documented partial remission, assessed up to 120 months
Complete remission
Time frame: From date of inclusion until the date of first documented complete remission, assessed up to 120 months
Relapses
Time frame: From date of inclusion until the date of first documented relapse, assessed up to 120 months
The change in proteinuria
Time frame: Through study completion, an average of 120 months
The change in eGFR
Time frame: Through study completion, an average of 120 months
Adverse events per 100 patient-years
Time frame: From date of inclusion until the date of first documented AE, assessed up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 30980653Barbour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vladimir Dobronravov, Professor, MD, PhD, DMedSci principal investigator
St. Petersburg State Pavlov Medical University
Zinaida Kochoyan, Nephrologist study chair
St. Petersburg State Pavlov Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunosuppressive treatment and Tonsillectomy in people with Primary IgA-nephropathy and High-risk, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Dobronravov, Professor, MD, PhD, DMedSci ((812)338-69-01, dobronravov@nephrolog.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.