Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
iptacopan: iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Study summary
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
Eligibility
Primary outcome measure(s)
- Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) — 6 months (double-blind)
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment. - Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) — 6 months (double-blind)
To evaluate the effect of iptacopan on proteinuria at 6 months. - Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms). — 12 months (double-blind and open-label)
To evaluate the effect of iptacopan on proteinuria at 12 months. - 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)
To evaluate the effect of iptacopan on proteinuria at 12 months.
Trial sites (87)
| Facility | City | Region | Status |
|---|---|---|---|
| Childrens Hospital Colorado | Aurora | Colorado | Recruiting |
| Nicklaus Childrens Hospital | Miami | Florida | Recruiting |
| Georgia Nephrology Research Inst | Lawrenceville | Georgia | Completed |
| IN University School of Med | Indianapolis | Indiana | Withdrawn |
| University of Iowa Health Care | Iowa City | Iowa | Recruiting |
| University of Iowa Health Care | Iowa City | Iowa | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | Withdrawn |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | Withdrawn |
| Hackensack Uni Medical Center | Hackensack | New Jersey | Withdrawn |
| Albany Medical Center | Albany | New York | Withdrawn |
| Col Uni Med Center New York Presby | New York | New York | Completed |
| Baylor Scott and White Research | Temple | Texas | Withdrawn |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
| Novartis Investigative Site | Córdoba | Córdoba Province | Withdrawn |
| Novartis Investigative Site | Buenos Aires | Argentina | Completed |
| Novartis Investigative Site | CABA | Argentina | Withdrawn |
| Novartis Investigative Site | Edegem | Belgium | Withdrawn |
| Novartis Investigative Site | Leuven | Belgium | Withdrawn |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | Active Not Recruiting |
| Novartis Investigative Site | Recife | Pernambuco | Recruiting |
| Novartis Investigative Site | Passo Fundo | Rio Grande do Sul | Recruiting |
| Novartis Investigative Site | Joinville | Santa Catarina | Withdrawn |
| Novartis Investigative Site | Santo André | São Paulo | Withdrawn |
| Novartis Investigative Site | São Paulo | São Paulo | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Withdrawn |
| Novartis Investigative Site | Salvador | Brazil | Recruiting |
| Novartis Investigative Site | London | Ontario | Completed |
| Novartis Investigative Site | Toronto | Ontario | Completed |
| Novartis Investigative Site | Montreal | Quebec | Withdrawn |
| Novartis Investigative Site | Guangzhou | Guangdong | Active Not Recruiting |
| Novartis Investigative Site | Wuhan | Hubei | Withdrawn |
| Novartis Investigative Site | Beijing | China | Active Not Recruiting |
| Novartis Investigative Site | Beijing | China | Recruiting |
| Novartis Investigative Site | Shanghai | China | Active Not Recruiting |
| Novartis Investigative Site | Prague | Czechia | Completed |
| Novartis Investigative Site | Lille | France | Completed |
| Novartis Investigative Site | Marseille | France | Withdrawn |
| Novartis Investigative Site | Montpellier | France | Withdrawn |
| Novartis Investigative Site | Paris | France | Completed |
| Novartis Investigative Site | Paris | France | Withdrawn |
+ 47 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04817618 on ClinicalTrials.gov ↗ ← All trials in the UK