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Not yet recruiting NCT07598448

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

— Observational Complement 3 Glomerulopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Complement 3 Glomerulopathy. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Experience With Iptacopan in Adult Patients With Complement 3 Glomerulopathy (C3G): A Multicenter, Observational, Retrospective Study of Patients Treated Through an Early Access Program in Spain

Overview

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.

Primary outcome measures

  • Baseline Demographics [Time frame: Baseline]
  • Height [Time frame: Baseline]
  • Weight [Time frame: Baseline]
  • Blood Pressure [Time frame: Baseline]
  • Number and Percentage of Patients by Clinical Characteristic [Time frame: Baseline]
  • Duration of Antibiotic Prophylaxis [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Number of Hospitalizations due to Severe Infection Before Iptacopan Initiation [Time frame: Baseline]
  • Age at C3G Diagnosis [Time frame: Baseline]
  • Number and Percentage of Patients by Clinical Features at First C3G Diagnosis [Time frame: Baseline]
  • Age at Last Kidney Transplantation Before Iptacopan Initiation [Time frame: Baseline]
Secondary outcome measures (12)
  • UPCR FMV During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • UPCR-24h During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Proteinuria-24h During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Urine Albumin-to-Creatinine Ratio (UACR) FMV During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • UACR-24h During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Albuminuria-24h During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Serum Albumin Concentration During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Serum Creatinine Concentration During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • eGFR During Iptacopan Treatment [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Difference Between Post- and Pre-Iptacopan Treatment eGFR Slopes [Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Number and Percentage of Patients With Kidney Failure [Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36]
  • Number and Percentage of Patients With a Kidney Transplant During Follow-up [Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07598448 · CLNP023B1ES01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗