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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 is a Phase 3 study of Primary IgA Nephropathy that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 365 participants. The trial reports 20 study locations across 13 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03643965
The ClinicalTrials.gov registry entry for NCT03643965 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calliditas Therapeutics AB, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.