Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07481084

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Baseline demographic

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    Age and sex

  2. Baseline clinical characteristics: Time of IgAN diagnosis

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis

  3. Baseline clinical characteristics: Baseline MEST-C

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    Scored according to the Oxford classification MEST-C criteria:

    • Mesangial hypercellularity (M0/M1)
    • Endocapillary hypercellularity (E0/E1)
    • Segmental glomerulo- sclerosis (S0/S1)
    • Tubular atrophy/interstitial fibrosis (T0/T1/T2)
    • Crescents (C0/C1/C2)

  4. Baseline clinical characteristics: Index Blood Pressure

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  5. Baseline clinical characteristics: Index eGFR

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  6. Baseline clinical characteristics: Index proteinuria

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  7. Baseline clinical characteristics: Index hematuria

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  8. Baseline clinical characteristics: Index serum albumin level

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  9. Baseline clinical characteristics: Index creatinine level

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  10. Baseline clinical characteristics: Number of participants by Index CKD stage

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    CKD stages:

    • Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m2)
    • Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m2)
    • Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m2)
    • Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m2)
    • Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m2)
    • Stage 5: Kidney failure (eGFR <15 mL/min/1.73m2)

  11. Baseline clinical characteristics: Number of participants by ESKD status

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    ESKD status is a binary variable, meaning with or without ESKD

  12. Baseline clinical characteristics: History of dialysis and kidney transplant

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    Number of participants with history of dialysis and kidney transplant

  13. Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  14. Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments

    Time frame: Index date (date of iptacopan or atrasentan initiation)

  15. Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant

    Time frame: Index date (date of iptacopan or atrasentan initiation)

    Baseline use of Endothelin Receptor Antagonist (ERA), A Proliferation Inducing Ligand (APRIL) / A Proliferation Inducing Ligand-B-cell Activating Factor (APRIL-BAFF) therapies, MMF, Hydroxychloroquine, nsMRA (Finerenone), Immunosuppressant

  16. Baseline clinical characteristics: Number of participants who have participated in a clinical trial

    Time frame: Index date (date of iptacopan or atrasentan initiation)

Secondary outcomes

  1. Number of participants by treatment sequence during baseline and follow-up period

    Time frame: up to 24-months

    Treatment sequence refers to longitudinal sequence of lines of treatment received across the study period. The date of treatment initiation and discontinuation will be recorded to determine the number of participants by sequence of treatment.

  2. Proteinuria

    Time frame: Up to 24-months

  3. Proteinuria control rate

    Time frame: Up to 24-months

    Proteinuria control rate (below 0.5g/day or 0.3g/day)

  4. eGFR

    Time frame: Up to 24-months

  5. Time from index date to complete remission

    Time frame: Up to 24-months

    complete remission defined as 24h proteinuria <0.3 g/d at various time intervals, depending on data availability (i.e. 6, 12, 18 and 24 months, etc.) until the date of treatment discontinuation (iptacopan or atrasentan), death, or loss to follow-up, whichever occurs first.

  6. Change in Chronic Kidney Disease (CKD) stage

    Time frame: Up to 24-months

  7. Number of patients progressing to kidney failure

    Time frame: Up to 24-months

  8. Number of patients receiving dialysis

    Time frame: Up to 24-months

  9. Number of patients progressing to of kidney transplantation

    Time frame: Up to 24-months

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.