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

NCT07481084 | Not Yet Recruiting

• 1 other identifier: CLNP023ACN01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

IgA Nephropathy

Keywords

China IgNITE; Iptacopan; atrasentan

Outcome Measures

Primary Outcomes (16)

• Baseline demographic

  Age and sex

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Time of IgAN diagnosis

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

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Baseline MEST-C

  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)

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index Blood Pressure

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index eGFR

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index proteinuria

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index hematuria

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index serum albumin level

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Index creatinine level

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Number of participants by Index CKD stage

  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)

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: Number of participants by ESKD status

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

  Index date (date of iptacopan or atrasentan initiation)

• Baseline clinical characteristics: History of dialysis and kidney transplant

  Number of participants with history of dialysis and kidney transplant

  Index date (date of iptacopan or atrasentan initiation)

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

  Index date (date of iptacopan or atrasentan initiation)

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

  Index date (date of iptacopan or atrasentan initiation)

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

  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

  Index date (date of iptacopan or atrasentan initiation)

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

  Index date (date of iptacopan or atrasentan initiation)

Secondary Outcomes (9)

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

  up to 24-months

• Proteinuria

  Up to 24-months

• Proteinuria control rate

  Up to 24-months

• eGFR

  Up to 24-months

• Time from index date to complete remission

  Up to 24-months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 18, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share