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Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
NCT04817618 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04817618 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Iowa, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04817618?
The interventions under investigation include: Placebo (DRUG), iptacopan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04817618?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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