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Not yet recruiting NCT07481084

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

— Observational IgA Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: IgA Nephropathy. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Baseline demographic [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Time of IgAN diagnosis [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Baseline MEST-C [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index Blood Pressure [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index eGFR [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index proteinuria [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index hematuria [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index serum albumin level [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Index creatinine level [Time frame: Index date (date of iptacopan or atrasentan initiation)]
  • Baseline clinical characteristics: Number of participants by Index CKD stage [Time frame: Index date (date of iptacopan or atrasentan initiation)]
Secondary outcome measures (9)
  • Number of participants by treatment sequence during baseline and follow-up period [Time frame: up to 24-months]
  • Proteinuria [Time frame: Up to 24-months]
  • Proteinuria control rate [Time frame: Up to 24-months]
  • eGFR [Time frame: Up to 24-months]
  • Time from index date to complete remission [Time frame: Up to 24-months]
  • Change in Chronic Kidney Disease (CKD) stage [Time frame: Up to 24-months]
  • Number of patients progressing to kidney failure [Time frame: Up to 24-months]
  • Number of patients receiving dialysis [Time frame: Up to 24-months]
  • Number of patients progressing to of kidney transplantation [Time frame: Up to 24-months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07481084 · CLNP023ACN01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗