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

Обзор

The study is planned to study specificity of the clinical course and treatment outcomes of C3 glomerulopathy (C3G) and Immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged under 18 years and 18 years and older in the Russian population in 2025-2028. The primary objective of the study is to estimate the frequency of complete or partial remission 12 months after morphological verification of the diagnosis. Assessment of demographic, clinical and laboratory, morphological characteristics at diagnosis and their relationship with the disease outcomes, primarily the disease progression and development of chronic renal failure, will allow assessing the efficacy of treatment used in real clinical practice, disease prognosis and factors associated with unfavourable outcomes.

Вмешательства

• Другое No intervention
  Patients will receive medical care in accordance with the routine practice of disease treatment

Первичные конечные точки

• Number and proportion of patients with overall (complete + partial) remission following the standard therapy in Russia [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Number and proportion of patients with complete remission [Срок оценки: 6 months; 12 months]
• Number and proportion of patients with partial remission [Срок оценки: 6 months; 12 months]
• Number and proportion of patients with relapse [Срок оценки: 6 months; 12 months]
• Number and proportion of patients with progression [Срок оценки: 6 months; 12 months]
• Number and proportion of patients with progression to end-stage kidney disease [Срок оценки: 6 months; 12 months]
• Number and proportion of died patients [Срок оценки: 6 months; 12 months]
• Time to start of maintenance dialysis [Срок оценки: 6 months; 12 months]
• Time from the diagnosis date to the start date of dialysis [Срок оценки: 6 months; 12 months]
• Time from the start date of treatment to the start date of dialysis [Срок оценки: 6 months; 12 months]
• Time from the diagnosis date to transplantation [Срок оценки: 6 months; 12 months]
• Time from the diagnosis date to the date of complete remission [Срок оценки: 6 months; 12 months]
• Time from the diagnosis date to the date of partial remission [Срок оценки: 6 months; 12 months]

Критерии участия

Критерии включения

• 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.
• Diagnosis of primary C3G or IC-MPGN confirmed by the results of morphological and clinical studies.
• The results of serum creatinine level, proteinuria determination obtained not earlier than 4 weeks before the kidney biopsy
• Index date (kidney biopsy) not earlier than March 2024 and not later than 11 months before signing the ICF
• 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.

Критерии исключения

• Patients participating in a clinical trial with the investigational product.
• Patients with monoclonal gammopathies (myeloma, B-cell lymphoma/lymphocytic leukemia, lymphoplasmacytoma)
• 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)
• 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)
• Patients with any clinically significant acute disease within 30 days prior to kidney biopsy
• Clinically significant concomitant kidney disease
• Treatment with pegcetacoplan

Other protocol-defined inclusion/exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06851845 · CLNP023B1RU01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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