AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

NCT02141672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2021-05-18

Study results available
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Summary

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

Conditions

Interventions

DRUG

Voclosporin High Dose

DRUG

Voclosporin Low Dose

DRUG

Placebo

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Anne Dooley, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-07-31
Completion
2017-01-31

Countries

  • United States
  • Bangladesh
  • Belarus
  • Bulgaria
  • China
  • Ecuador
  • Georgia
  • Guatemala
  • Mexico
  • Philippines
  • Poland
  • Russia
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Sri Lanka
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141672 on ClinicalTrials.gov