Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study

Launched by NOVARTIS PHARMACEUTICALS · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study two specific kidney diseases: C3 glomerulopathy (C3G) and immune-complex membranoproliferative glomerulonephritis (IC-MPGN). The researchers want to understand how these conditions progress and how well they respond to treatment over a 12-month period in patients from Russia, both children and adults. By examining the characteristics of patients at the time of diagnosis and their treatment outcomes, the study aims to identify factors that may influence the success of the treatments used and the overall prognosis of the diseases.

To participate in the trial, individuals must be willing to give consent (or have a parent or guardian do so if they are under 18) and have a confirmed diagnosis of C3G or IC-MPGN. They should also have kidney function that meets certain criteria. However, certain conditions, such as recent infections or other significant kidney diseases, may exclude someone from participating. Throughout the trial, participants can expect to undergo assessments that will help doctors understand how effective the treatments are in real-world settings. This study is not yet recruiting participants, but it is set to take place from 2025 to 2028.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing to sign informed consent form. If the patient is under 18 years of age, the parent or legally acceptable representative of the child/adolescent who can participate in this study also signs the consent form.
• • 2. Diagnosis of primary C3G or IC-MPGN confirmed by the results of morphological and clinical studies.
• • 3. The results of serum creatinine level, proteinuria determination obtained not earlier than 4 weeks before the kidney biopsy
• • 4. Index date (kidney biopsy) not earlier than March 2024 and not later than 11 months before signing the ICF
• • 5. The estimated baseline GFR (using the CKD-EPI formula for persons aged over 18 years and the modified Schwarz formula for children) or the measured GFR is ≥30 mL/min per 1.73 m2.
• Exclusion Criteria:
• • 1. Patients participating in a clinical trial with the investigational product.
• • 2. Patients with monoclonal gammopathies (myeloma, B-cell lymphoma/lymphocytic leukemia, lymphoplasmacytoma)
• • 3. Patients with systemic autoimmune diseases and vasculitis (systemic lupus erythematosus, systemic sclerosis, dermatomyositis, mixed connective tissue disease, Sjogren syndrome, Henoch-Schönlein purpura, ANCA vasculitis, cryoglobulinemia)
• • 4. Patients with current or recent infections (viral hepatitis B, viral hepatitis C, infective endocarditis or sepsis, infected ventriculoatrial shunts, abscesses, meningococcal and other bacterial infections, protozoan infections)
• • 5. Patients with any clinically significant acute disease within 30 days prior to kidney biopsy
• • 6. Clinically significant concomitant kidney disease
• • 7. Treatment with pegcetacoplan
• • Other protocol-defined inclusion/exclusion criteria may apply.