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
Qualifiers
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
Treatments tested in this trial
- Immunosuppressive treatment
- Tonsillectomy
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov