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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Baseline Demographics — Baseline
• Height — Baseline
• Weight — Baseline
• Blood Pressure — Baseline
  Systolic and diastolic blood pressure.
• Number and Percentage of Patients by Clinical Characteristic — Baseline
  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
• 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 — Baseline
  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
• 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 — Baseline
  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
• 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 — Baseline
  Total protein excretion from 24-hour collection.
• Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence — Baseline

Trial sites (2)

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