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NCT04817618 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
A Phase 3 study of C3G, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT04817618: Recruiting Phase 3 study of C3G, sponsored by Novartis Pharmaceuticals.
NCT04817618 is a Phase 3 study of C3G that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 98 participants, above the 53-participant average among 3 other C3G trials with a reported enrollment target (85% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817618, a Phase 3 study of C3G, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG iptacopan
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Edegem
- Novartis Investigative Site - Leuven
Iowa
- University of Iowa Health Care - Iowa City
- University of Iowa Health Care - Iowa City
New York
- Albany Medical Center - Albany
- Col Uni Med Center New York Presby - New York
Colorado
- Childrens Hospital Colorado - Aurora
Florida
- Nicklaus Childrens Hospital - Miami
Georgia
- Georgia Nephrology Research Inst - Lawrenceville
Indiana
- IN University School of Med - Indianapolis
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2027-01-29 |
| Phase | Phase 3 |
What NCT04817618 shows while recruiting
NCT04817618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 53-participant average among 3 other C3G trials with a reported enrollment target (85% higher).
The record links to 1 condition, with C3G appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04817618 names 20 study sites across 15 states, led by Other, Iowa, New York.
Frequently Asked Questions
What is clinical trial NCT04817618 about?
NCT04817618 is a clinical study titled "Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.". 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 safet...
What is the current status of trial NCT04817618?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2021-07-28. Estimated completion is 2027-01-29.
What conditions does trial NCT04817618 study?
This clinical trial studies the following conditions: C3G.
What interventions are being tested in trial NCT04817618?
The interventions under investigation include: Placebo (DRUG), iptacopan (DRUG).
Who is sponsoring clinical trial NCT04817618?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04817618 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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