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NCT06797518 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
A Phase 2 study of Immunoglobulin A Nephropathy and Glomerulonephritis, IGA, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 14
- Study locations
NCT06797518: Recruiting Phase 2 study of Immunoglobulin A Nephropathy and Glomerulonephritis, IGA, sponsored by Novartis Pharmaceuticals.
NCT06797518 is a Phase 2 study of Immunoglobulin A Nephropathy and Glomerulonephritis, IGA that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 303-participant average among 13 other Immunoglobulin A Nephropathy trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06797518, a Phase 2 study of Immunoglobulin A Nephropathy and Glomerulonephritis, IGA, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 14
- Study locations
Study Summary
A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.
Primary Outcome
Mesangial C3c deposition is assessed by intensity of immunofluorescence (IF) staining using the following grading system: 0 (absent) 1 (+) 2 (++) 3 (+++)
Conditions Studied
Interventions
- DRUG Iptacopan
Study Locations (14)
Other
- Novartis Investigative Site - Ashdod
- Novartis Investigative Site - Hadera
- Novartis Investigative Site - Haifa
- Novartis Investigative Site - Nahariya
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- OSU Wexner Medical Center - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
California
- UCLA Medical Center - Los Angeles
Georgia
- Nephronet Clinical - Buford
Idaho
- CaRe Research - Chubbuck
Nevada
- DaVita Clinical Research - Las Vegas
Texas
- Prolato Clinical Research Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-21 |
| Est. Completion | 2027-11-27 |
| Phase | Phase 2 |
What NCT06797518 shows while recruiting
NCT06797518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 303-participant average among 13 other Immunoglobulin A Nephropathy trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Immunoglobulin A Nephropathy appearing as the primary indexed condition, and to 1 intervention - of which Iptacopan is the first listed.
NCT06797518 lists 14 locations in 10 states (Other, Ohio, Alabama).
Frequently Asked Questions
What is clinical trial NCT06797518 about?
NCT06797518 is a clinical study titled "Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN". A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quant...
What is the current status of trial NCT06797518?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-02-21. Estimated completion is 2027-11-27.
What conditions does trial NCT06797518 study?
This clinical trial studies the following conditions: Immunoglobulin A Nephropathy, Glomerulonephritis, IGA.
What interventions are being tested in trial NCT06797518?
The interventions under investigation include: Iptacopan (DRUG).
Who is sponsoring clinical trial NCT06797518?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06797518 being conducted?
This trial has 14 study locations across Alabama, California, Georgia, Idaho, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06797518's enrollment target sits among peer trials
20 14th of 13 the lowest of 13 other Immunoglobulin A Nephropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Immunoglobulin A Nephropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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