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Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

NCT03597464 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-12-14

Study results available
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Summary

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

Conditions

Interventions

DRUG

Voclosporin

Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)

DRUG

Placebo Oral Capsule

Voclosporin placebo, oral, 3 capsules twice daily (BID)

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

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
2019-09-29
Primary Completion
2021-10-07
Completion
2021-10-07
FDA Drug
Yes

Countries

  • United States

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 NCT03597464 on ClinicalTrials.gov