IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection

Официальное название

China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection

Обзор

The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months

Первичные конечные точки

• Baseline demographic [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Time of IgAN diagnosis [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Baseline MEST-C [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index Blood Pressure [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index eGFR [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index proteinuria [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index hematuria [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index serum albumin level [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Index creatinine level [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]
• Baseline clinical characteristics: Number of participants by Index CKD stage [Срок оценки: Index date (date of iptacopan or atrasentan initiation)]

Вторичные конечные точки (9)

• Number of participants by treatment sequence during baseline and follow-up period [Срок оценки: up to 24-months]
• Proteinuria [Срок оценки: Up to 24-months]
• Proteinuria control rate [Срок оценки: Up to 24-months]
• eGFR [Срок оценки: Up to 24-months]
• Time from index date to complete remission [Срок оценки: Up to 24-months]
• Change in Chronic Kidney Disease (CKD) stage [Срок оценки: Up to 24-months]
• Number of patients progressing to kidney failure [Срок оценки: Up to 24-months]
• Number of patients receiving dialysis [Срок оценки: Up to 24-months]
• Number of patients progressing to of kidney transplantation [Срок оценки: Up to 24-months]

Критерии участия

Критерии включения

• Biopsy confirmed diagnosis of IgAN.
• Age ≥18 years at index date.
• Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.
• Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform.

Критерии исключения

• Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
• Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.
• Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician.
• Pregnancy or other contraindications for iptacopan and/or atrasentan
• Insufficient medical records available for the baseline and follow-up periods.

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: NCT07481084 · CLNP023ACN01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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