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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: Completed Phase 3 study of Lupus Nephritis, sponsored by Human Genome Sciences Inc., a GSK Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinin
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 |
What the finished NCT01639339 record still lists
NCT01639339 is an interventional study that assigns participants to a tested intervention. The registered 448 participants enrollment target is mid-sized for trials with a published cap, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (52% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01639339's enrollment target sits among peer trials
448 4th of 30 higher than 27 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis 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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