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Aurinia Renal Response in Active Lupus With Voclosporin

NCT03021499 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2023-03-27

Study results available
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Summary

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

Conditions

Interventions

DRUG

Voclosporin

calcineurin inhibitor

DRUG

Placebo Oral Capsule

matching placebo capsule

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Samir Parikh, MD · Ohio State University

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
2017-05-17
Primary Completion
2019-09-24
Completion
2019-10-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belarus
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Croatia
  • Dominican Republic
  • Guatemala
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • North Macedonia
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT03021499 on ClinicalTrials.gov