Aurinia Early Urinary Protein Reduction Predicts Response

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT02949973
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

Key Dates

Start date
Jun 30, 2015
Status verified
Mar 2021
Primary completion
Dec 31, 2016
Completion
Feb 17, 2017

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Voclosporin
    Voclosporin, oral, 23.7 mg twice daily (BID)

Primary Outcome Measure

Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) [ Time Frame: 24 weeks ]

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