NCT07074951Recruiting
Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)
Source: ClinicalTrials.gov · Last updated 20 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 10 Mar 2013
- Primary completion date
- 10 Mar 2026
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- IgA nephropathy
- NCT number
- NCT07074951
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 10 Mar 2013 to the primary completion date, 10 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with any co-existing kidney disease
- Patients with diabetes mellitus
Lab values
- eGFR ≤20 ml/min/1.73m2
Age
- Age \<18 or \>75 years;
Other
- Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \<1.0 g
- Contraindications to IST or TE
- Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Institute of Nephrology (Pavlov Medical University) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| St. Petersburg State Pavlov Medical University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.