A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain

NCT07598448 | Not Yet Recruiting

• 1 other identifier: CLNP023B1ES01
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.

Conditions

Complement 3 Glomerulopathy

Keywords

Complement 3 Glomerulopathy; C3G; Iptacopan; Factor B inhibition; Alternative Complement Pathway; Early Access Program

Outcome Measures

Primary Outcomes (21)

• Baseline Demographics

  Baseline

• Height

  Baseline

• Weight

  Baseline

• Blood Pressure

  Systolic and diastolic blood pressure.

  Baseline

• Number and Percentage of Patients by Clinical Characteristic

  Clinical characteristics include: * Kidney status * History of dialysis * Presence of edema * Comorbidities * C3G histology subtype * Previous medication * Vaccination status * Receipt of antibiotic prophylaxis in addition to vaccination * History of severe infections

  Baseline

• Duration of Antibiotic Prophylaxis

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

• Number of Hospitalizations due to Severe Infection Before Iptacopan Initiation

  Baseline

• Age at C3G Diagnosis

  Baseline

• Number and Percentage of Patients by Clinical Features at First C3G Diagnosis

  Clinical features include: * Clinical presentation (nephrotic, nephritic, isolated non-nephrotic proteinuria, asymptomatic urinary abnormalities) * Presence of pathogenic variants in complement-related genes * Presence of autoantibodies against complement components

  Baseline

• Age at Last Kidney Transplantation Before Iptacopan Initiation

  Baseline

• Number of Kidney Transplants Before Iptacopan Initiation

  Baseline

• Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation

  Clinical features include: * Previous recurrence with kidney failure * Kidney donor type * Highly sensitized (yes/no) * Immediate graft function * Type of induction therapy * Type of maintenance immunosuppressive (IS) therapy * Kidney transplant rejection episode and type of rejection

  Baseline

• Duration of Cold Ischemia for the Last Kidney Transplant Before Iptacopan Initiation

  Baseline

• Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)

  Baseline

• Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant

  Baseline

• Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence

  Baseline

• eGFR at Last Post-transplant C3G Recurrence

  Baseline

• Serum Albumin Concentration at Last Post-transplant C3G Recurrence

  Baseline

• Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence

  Baseline

• Proteinuria-24h at Last Post-transplant C3G Recurrence

  Total protein excretion from 24-hour collection.

  Baseline

• Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence

  Baseline

Secondary Outcomes (42)

• UPCR FMV During Iptacopan Treatment

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

• UPCR-24h During Iptacopan Treatment

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

• Proteinuria-24h During Iptacopan Treatment

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

• Urine Albumin-to-Creatinine Ratio (UACR) FMV During Iptacopan Treatment

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

• UACR-24h During Iptacopan Treatment

  Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Study Arms (1)

Iptacopan Cohort

Adult patients with C3G who received iptacopan through an EAP in Spain.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of C3G who have received at least one dose of iptacopan through an EAP from 01 October 2020 through 30 June 2025.

You may qualify if:

• Adult patients (≥18 years).
• Biopsy-confirmed C3G.
• Patients who have received at least one dose of iptacopan through an EAP from October 2020 to June 2025.

You may not qualify if:

• \. Patients treated with iptacopan through an EAP for indications other than C3G.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Glomerulonephritis, Membranoproliferative

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share