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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT03597464
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin — DRUG
    Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)
  • Placebo Oral Capsule — DRUG
    Voclosporin placebo, oral, 3 capsules twice daily (BID)

Study Details

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).

Key Dates

Start date
Sep 29, 2019
Status verified
Nov 2022
Primary completion
Oct 7, 2021
Completion
Oct 7, 2021

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Voclosporin
    Voclosporin
  • Placebo Comparator: Placebo Oral Capsule
    Placebo

Primary Outcome Measure

Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. [ Time Frame: Month 12 (AURORA 2 baseline) to Month 36 ]

Locations (1)

FacilityCityStateZIPSite coordinators
AURORA Investigative CenterOklahoma CityOklahoma73104-

Find similar trials in Oklahoma City, OK

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
AURORA Investigative Center· Oklahoma City, OK

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