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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04817618
The ClinicalTrials.gov registry entry for NCT04817618 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 53-participant average among 3 other C3G trials with a reported enrollment target (85% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.