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NCT03453619 · ClinicalTrials.gov registry record · Phase 2
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
A Phase 2 study of Lupus Nephritis and IgA Nephropathy, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 17
- Study locations
NCT03453619: Completed Phase 2 study of Lupus Nephritis and IgA Nephropathy, sponsored by Apellis Pharmaceuticals.
NCT03453619 is a Phase 2 study of Lupus Nephritis and IgA Nephropathy that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 21 participants, below the 310-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (93% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03453619, a Phase 2 study of Lupus Nephritis and IgA Nephropathy, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 17
- Study locations
Study Summary
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
Primary Outcome
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Conditions Studied
Interventions
- DRUG APL-2
Study Locations (17)
Colorado
- Children's Hospital Colorado - Aurora
- HealthONE Physician Care, Rocky Mountain Hospital for Children - Denver
New York
- Davita Clinical Research - The Bronx
- Westchester Medical Center - Valhalla
Virginia
- Washington Nephrology Associates - Alexandria
- Davita Clinical Research - Chesapeake
California
- Stanford University - Stanford
District of Columbia
- Washington Nephrology Associates - Washington D.C.
Florida
- Horizon Research Group - Coral Gables
Georgia
- Emory University - Atlanta
Indiana
- American Research LLC - Jeffersonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-02-26 |
| Est. Completion | 2023-08-26 |
| Phase | Phase 2 |
What the finished NCT03453619 record still lists
NCT03453619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 310-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention - of which APL-2 is the first listed.
NCT03453619 lists 17 locations in 14 states (Colorado, New York, Virginia).
Frequently Asked Questions
What is clinical trial NCT03453619 about?
NCT03453619 is a clinical study titled "Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies". This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
What is the current status of trial NCT03453619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-02-26. Estimated completion is 2023-08-26.
What conditions does trial NCT03453619 study?
This clinical trial studies the following conditions: Lupus Nephritis, IgA Nephropathy, Membranous Nephropathy, C3 Glomerulonephritis, Dense Deposit Disease.
What interventions are being tested in trial NCT03453619?
The interventions under investigation include: APL-2 (DRUG).
Who is sponsoring clinical trial NCT03453619?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03453619 being conducted?
This trial has 17 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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