Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
NCT04817618 · APPEAR-C3G Phase 3Recruiting
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 98 (estimated)
- Start date
- 28 Jul 2021
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027
- Last update posted
- 13 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 2
Interventions
- Placebo Drug
- iptacopan Drug
Conditions and primary outcome
- C3G
Primary outcome
Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) (6 months (double-blind)); Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) (6 months (double-blind)); Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms). (12 months (double-blind and open-label)); Change in log-transformed UPCR from the 6-month visit to the 12-month visit in the placebo arm (From month 6 to month 12 (open-label))
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedOral iptacopan therapy in patients with C3 glomerulopathy: a randomised, double-blind, parallel group, multicentre, placebo-controlled, phase 3 study.
Lancet (London, England) · 2025 Oct 11
PubMed 41016405 (opens in a new tab)DOI 10.1016/S0140-6736(25)01148-1 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04817618 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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