NCT07481084Not yet recruiting
IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 29 May 2026
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- IgA nephropathy
- NCT number
- NCT07481084
What you commit to
- Study type: Observational
- Planned participants: 80
- From 29 May 2026 to the primary completion date, 30 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
- Pregnancy or other contraindications for iptacopan and/or atrasentan
- Insufficient medical records available for the baseline and follow-up periods.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.