Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

NCT01639339 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 448 participants
Start Date 2012-07-12
Est. Completion 2020-03-12
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 448 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences Inc., a GSK Company, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01639339 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01639339?

This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial