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NCT03643965 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
A Phase 3 study of Primary IgA Nephropathy, sponsored by Calliditas Therapeutics AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
- 20
- Study locations
NCT03643965: Completed Phase 3 study of Primary IgA Nephropathy, sponsored by Calliditas Therapeutics AB.
NCT03643965 is a Phase 3 study of Primary IgA Nephropathy that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 365 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03643965, a Phase 3 study of Primary IgA Nephropathy, has completed, sponsored by Calliditas Therapeutics AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
- 20
- Study locations
Study Summary
The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).
Primary Outcome
Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline. Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Nefecon
Study Locations (20)
Florida
- University of Florida-Gainesville - Gainesville
- Omega Research Maitland, 7912 Forest City Rd. - Orlando
- Omega Research Maitland - Orlando
California
- Stanford University Medical Center, 777 Welch Rd - Palo Alto
- Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street - Torrance
Colorado
- University of Colorado Health Science Center, 1200 East 19th Av. - Aurora
- Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St. - Westminster
Illinois
- Northwestern University the Feinberg School of Medicine, 633 North St. Clair - Chicago
- Northshore University Health System, 2650 Ridge Av. - Evanston
Kentucky
- University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor - Lexington
- University of Louisville-Nephrology - Louisville
New York
- Queens Hospital Centre - Jamaica
- Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place - New York
Alabama
- University of Alabama at Birmingham, 1720 2nd Ave South - Birmingham
Arizona
- Univ of Arizona, 1501 N Campbell Ave - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 3 |
What the finished NCT03643965 record still lists
NCT03643965 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Primary IgA Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03643965 names 20 study sites across 13 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03643965 about?
NCT03643965 is a clinical study titled "Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy". The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotens...
What is the current status of trial NCT03643965?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2018-09-05. Estimated completion is 2023-07-10.
What conditions does trial NCT03643965 study?
This clinical trial studies the following conditions: Primary IgA Nephropathy.
What interventions are being tested in trial NCT03643965?
The interventions under investigation include: Placebo oral capsule (DRUG), Nefecon (DRUG).
Who is sponsoring clinical trial NCT03643965?
This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03643965 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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