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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

35 Participants
are grouped into 1 trial group
Group A: Iptacopan Cohort

Trial outcomes

Primary outcomes

1

Baseline Demographics

Time frame
Baseline
2

Height

Time frame
Baseline
3

Weight

Time frame
Baseline
4

Blood Pressure

Systolic and diastolic blood pressure.

Time frame
Baseline

Secondary outcomes

1

UPCR FMV During Iptacopan Treatment

Time frame
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
2

UPCR-24h During Iptacopan Treatment

UPCR from 24-hour collection.

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

Proteinuria-24h During Iptacopan Treatment

Total protein excretion from 24-hour collection.

Time frame
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
4

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

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

Other outcomes

Sponsors and contacts

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