Not Yet RecruitingNot Applicable

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

80 participantsStarted 2026-05-29

Plain-language summary

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

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Baseline demographic

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Time of IgAN diagnosis

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline MEST-C

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index Blood Pressure

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index eGFR

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index proteinuria

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index hematuria

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Trial details

NCT IDNCT07481084

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-03-30

Contact for this trial

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

View on ClinicalTrials.gov More IgA Nephropathy trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Baseline demographic

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Time of IgAN diagnosis

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline MEST-C

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index Blood Pressure

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index eGFR

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index proteinuria

Timeframe: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index hematuria

Timeframe: Index date (date of iptacopan or atrasentan initiation)