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CHART-C3G/CLNP023B12011

NCT07331259 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2026-01-09

No results posted yet for this study

Summary

This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.

Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

Conditions

  • C3 Glomerulopathy
  • Complement-mediated Kidney Disease
  • Proteinuria

Interventions

OTHER

Iptacopan

There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.

Sponsors & Collaborators

Principal Investigators

  • Novartis pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-03-01
Completion
2027-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331259 on ClinicalTrials.gov