Aurinia Renal Response in Active Lupus With Voclosporin

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Voclosporin — DRUG
  calcineurin inhibitor
• Placebo Oral Capsule — DRUG
  matching placebo capsule

Study Details

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.

Key Dates

Start date

May 17, 2017

Status verified

Mar 2023

Primary completion

Sep 24, 2019

Completion

Oct 10, 2019

Study Design

Enrollment

358 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Voclosporin
  oral, 23.7 mg twice daily (BID)
• Placebo Comparator: Placebo Oral Capsule
  Voclosporin placebo, oral, 3 capsules twice daily (BID)

Primary Outcome Measure

Number of Participants With Adjudicated Renal Response at Week 52 [ Time Frame: 52 Weeks ]

Locations (59)

Find similar trials in Huntsville, AL

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