CHART-C3G/CLNP023B12011

Официальное название

C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)

Обзор

This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up. Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany. The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

Подробное описание

Until recently, there are no approved disease-specific treatments for C3G, although there is significant interest in the therapeutic potential of complement inhibition.

Iptacopan, the first oral effective targeted disease-modifying proximal complement inhibitor developed by Novartis, has been approved in April 2025 for the treatment of adults with C3G.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

By analyzing key endpoints such as age, sex, ethnicity, BMI, clinical symptoms, proteinuria, blood pressure, serum creatinine, eGFR, serum C3 levels, and renal histological parameters, we aim to better understand disease progression and treatment outcomes.

Additionally, we will assess CKD stages, history of kidney failure, dialysis status, transplant status, and comorbidities to identify the characteristics of patients treated with iptacopan.

Вмешательства

• Другое Iptacopan
  There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.

Первичные конечные точки

• Demographics: Number of patients by age [Срок оценки: Baseline]
• Demographics: Number of patients by sex [Срок оценки: Baseline]
• Demographics: Number of patients by site [Срок оценки: Baseline]
• Demographics: Body mass index [Срок оценки: Baseline]
• Demographics: Number of patinets with Biopsy confirming C3G [Срок оценки: Baseline]
• Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR [Срок оценки: Baseline]
• Proteinuria - Number of participants by spot uPCR [Срок оценки: Baseline]
• Proteinuria, 24-hour uPCR in g/g [Срок оценки: Baseline]
• Proteinuria, spot uPCR in g/g [Срок оценки: Baseline]
• Clinical symptoms: Albuminuria [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Clinical events and outcomes: Number of participants with kindney failure during follow-up [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Number of participants with dialysis during follow-up [Срок оценки: Up to 12 months]
• Clinical events and outcomes:Time from kidney failure to first dialysis (months) [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Time from baseline to first dialysis (months) [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Time from kidney failure to maintenance dialysis (months) [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Time from C3G diagnosis to maintenance dialysis (months) [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Time from baseline to maintenance dialysis (months) [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Number of participants with complete remission (controlled) of C3G during follow-up [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Number of participants with nephrotic-range and non-nephrotic range proteinuria during follow-up [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Number of participants with renal relapse, progression to a higher CKD stage, or chronic renal replacement therapy during follow-up [Срок оценки: Up to 12 months]
• Clinical events and outcomes: Number of transplant failures per patient during follow-up [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• Clinical diagnosis of C3G (confirmed by biopsy, only if available)
• Aged ≥18 years at time of index date.
• At least 6 months of baseline period preceding index date.
• Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.

Критерии исключения

• Interventional C3G clinical trial participation

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: NCT07331259 · CLNP023B12011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗