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NCT01639339 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
A Phase 3 study of Lupus Nephritis, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
- 20
- Study locations
NCT01639339 is a Phase 3 study of Lupus Nephritis that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 448 participants, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT01639339, a Phase 3 study of Lupus Nephritis, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Conditions Studied
Interventions
- BIOLOGICAL Placebo plus standard therapy
- BIOLOGICAL Belimumab 10 mg/kg plus standard therapy
- DRUG Standard therapy
Study Locations (20)
New York
- GSK Investigational Site - Brooklyn
- GSK Investigational Site - Great Neck
- GSK Investigational Site - Manhasset
- GSK Investigational Site - New York
- GSK Investigational Site - New York
California
- GSK Investigational Site - La Palma
- GSK Investigational Site - San Leandro
- GSK Investigational Site - Torrance
Florida
- GSK Investigational Site - Gainesville
- GSK Investigational Site - Miami
Pennsylvania
- GSK Investigational Site - Bethlehem
- GSK Investigational Site - Philadelphia
Missouri
- GSK Investigational Site - St Louis
North Carolina
- GSK Investigational Site - Chapel Hill
Ohio
- GSK Investigational Site - Columbus
South Carolina
- GSK Investigational Site - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2012-07-12 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01639339
The ClinicalTrials.gov registry entry for NCT01639339 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 448 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (52% higher). The listed sponsor is Human Genome Sciences Inc., a GSK Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo plus standard therapy is the first listed.
NCT01639339 reports 20 study locations spanning 12 distinct geographic areas - top geographies include New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01639339 about?
NCT01639339 is a clinical study titled "Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis". The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
What is the current status of trial NCT01639339?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2012-07-12. Estimated completion is 2020-03-12.
What conditions does trial NCT01639339 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT01639339?
The interventions under investigation include: Placebo plus standard therapy (BIOLOGICAL), Belimumab 10 mg/kg plus standard therapy (BIOLOGICAL), Standard therapy (DRUG).
Who is sponsoring clinical trial NCT01639339?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01639339 being conducted?
This trial has 20 study locations across California, Florida, Missouri, New York, North Carolina. 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.