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NCT03945318 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
A Phase 1 study of IgA Nephropathy, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 16
- Study locations
NCT03945318: Active Phase 1 study of IgA Nephropathy, sponsored by Novartis Pharmaceuticals.
NCT03945318 is a Phase 1 study of IgA Nephropathy that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 103 participants, below the 157-participant average among 10 other IgA Nephropathy trials with a reported enrollment target (34% lower). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945318, a Phase 1 study of IgA Nephropathy, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 16
- Study locations
Study Summary
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
Primary Outcome
TEAEs and SAEs are assessed throughout each participant's study participation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Conditions Studied
Interventions
- DRUG BION-1301 Single Dose
- DRUG Placebo Single Dose
- DRUG BION-1301 Multiple Doses
- DRUG Placebo Multiple Doses
Study Locations (16)
Gyeonggi-do
- Hallym University Sacred Heart Hospital - Anyang-si
- National Health Insurance Service Ilsan Hospital - Goyang-si
- Hanyang University Guri Hostpital - Guri-si
- Seoul National University Bundang Hospital - Seongnam-si
Texas
- Liberty Research Center - Arlington
- Liberty Research Center - Dallas
- Prolato Clinical Research Center - Houston
Florida
- Nephrology Associates of Central Florida - Orlando
- Elixia Tampa, LLC - Tampa
California
- Amicis Research Center - Northridge
Colorado
- Colorado Kidney Care, P.C. - Denver
New York
- New York Nephrology - Clifton Park
Oklahoma
- Chris Sholer, P.C. - Oklahoma City
Chungcheongnam-do
- Soon Chun Hyang University Hospital Cheonan - Cheonan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2026-04-13 |
| Phase | Phase 1 |
What the registry record for NCT03945318 still lists
NCT03945318 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 157-participant average among 10 other IgA Nephropathy trials with a reported enrollment target (34% lower).
The record links to 1 condition, with IgA Nephropathy appearing as the primary indexed condition, and to 4 interventions - of which BION-1301 Single Dose is the first listed.
NCT03945318 lists 16 locations in 10 states (Gyeonggi-do, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT03945318 about?
NCT03945318 is a clinical study titled "Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)". Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
What is the current status of trial NCT03945318?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2019-04-08. Estimated completion is 2026-04-13.
What conditions does trial NCT03945318 study?
This clinical trial studies the following conditions: IgA Nephropathy.
What interventions are being tested in trial NCT03945318?
The interventions under investigation include: BION-1301 Single Dose (DRUG), Placebo Single Dose (DRUG), BION-1301 Multiple Doses (DRUG), Placebo Multiple Doses (DRUG).
Who is sponsoring clinical trial NCT03945318?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03945318 being conducted?
This trial has 16 study locations across California, Colorado, Florida, New York, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03945318's enrollment target sits among peer trials
103 4th of 10 higher than 5 of 10 other IgA Nephropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other IgA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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