NCT06851845尚未招募不适用
Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Number and proportion of patients with overall (complete + partial) remission following the standard therapy in Russia
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number and proportion of patients with overall (complete + partial) remission following the standard therapy in Russia
时间窗: 12 months
Complete response is defined as proteinuria \<0.5 g/24 h with stable eGFR (less than 20% decline in eGFR from baseline without the need for renal replacement therapy). Partial response is defined as reduction of proteinuria at stable eGFR (no decrease of \>20% of baseline value): \>50% (from baseline) (in those with proteinuria \<3.5 g/day or \>3.5 g/day but without nephrotic syndrome (NS)) OR in ≥50% from baseline accompanied by a regression of NS (NS \<3.5 g/day and blood albumin ≥30 g/L).
次要结局
- Number and proportion of patients with complete remission(6 months; 12 months)
- Number and proportion of patients with partial remission(6 months; 12 months)
- Number and proportion of patients with relapse(6 months; 12 months)
- Number and proportion of patients with progression(6 months; 12 months)
- Number and proportion of patients with progression to end-stage kidney disease(6 months; 12 months)
- Number and proportion of died patients(6 months; 12 months)
- Time to start of maintenance dialysis(6 months; 12 months)
- Time from the diagnosis date to the start date of dialysis(6 months; 12 months)
- Time from the start date of treatment to the start date of dialysis(6 months; 12 months)
- Time from the diagnosis date to transplantation(6 months; 12 months)
- Time from the diagnosis date to the date of complete remission(6 months; 12 months)
- Time from the diagnosis date to the date of partial remission(6 months; 12 months)
- Time from the diagnosis date to the date of overall remission (complete and partial remission)(6 months; 12 months)
- Time to progression(6 months; 12 months)
- Number and proportion of patients with a) an increase in eGFR by ≥15% from the baseline; b) decrease in eGFR by ≥15% from the baseline; c) stable eGFR (change up to 15%)(6 months; 12 months)
- Time to 30%, 40% and 50% decline in eGFR(6 months; 12 months)
- Number and proportion of patients with proteinuria >1 g/24 h and eGFR ≥30 mL/min per 1.73 m2(6 months; 12 months)
- Number and proportion of patients with nephrotic syndrome(6 months; 12 months)
- Demographic and clinical characteristics of patients with primary C3G (cohort 1), IC-MPGN (cohort 2), and overall(Baseline)
- Number of patients by morphologically verified disease form in patients with primary C3G (cohort 1), IC-MPGN (cohort 2), and overall(Baseline)
- Number of patients with presence of serum complement markers, serum factor H, rare genetic variants(Baseline)
- Number and proportion of patients stratified by treatment sequence and specific regimen of treatment(Baseline; 6 months; 12 months)
- Number and proportion of patients that discontinued a specific regimen of treatment at each line of therapy at any time during follow-up and reason for discontinuation for each cohort(Baseline; 6 months; 12 months)
- Number of exposed doses for non-continuous treatments (e.g., pulse therapy, rituximab infusion) in each cohort(Baseline; 6 months; 12 months)
- Number of patients by qualitative, semi-quantitative and quantitative scores of active and chronic lesions(Baseline)
- Number of patients with signs of thrombotic microangiopathy in the biopsy specimen(Baseline)
- Number of patients with acute tubular necrosis(Baseline)
- Number of patients with presence of C1q, IgA, IgM, IgG, C3, kappa chain, lambda chain deposits(Baseline)
- Patient-reported outcomes for C3G (cohort 1), IC-MPGN (cohort 2), and overall(12 months)
- Number of patients (%) with adverse events/serious adverse events by treatment option(12 months)
- Change from baseline of systolic and diastolic blood pressure (BP) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline serum creatinine level (µmol/L) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline estimated glomerular filtration rate (eGFR) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline eGFR rate of change over time (eGFR slope) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline chronic kidney disease (CKD) stage (number of patients, %) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline red blood cell count in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline RBC casts in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline daily proteinuria (proteinuria in g/24 hours) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline proteinuria >1 g/24 h in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline eGFR ≥30 mL/min per 1.73 m2 in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
- Change from baseline number of patients with nephrotic syndrome (%) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall(6 months; 12 months)
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