Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

Part of paid clinical trials in Denver, Colorado.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT03598036
Phase
PHASE2
Status
Terminated

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

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

Interventions

  • Voclosporin — DRUG
    Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID). The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.

Study Details

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

Key Dates

Start date
Jun 21, 2018
Status verified
Jun 2020
Primary completion
May 19, 2020
Completion
May 19, 2020

Study Design

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

Arms

  • Experimental: Voclosporin
    Cohort 1: Maximum dose of 3 capsules (7.9mg) BID Cohort 2 Dosing to be decided based on the safety from the first 5 or 6 subjects in Cohort 1.

Primary Outcome Measure

Proportion of Subjects With Remission of Proteinuria [ Time Frame: 24 weeks ]

Locations (21)

FacilityCityStateZIPSite coordinators
FSGS Investigative CenterDenverColorado80213-
FSGS Investigative CenterWinter ParkFlorida32789-
FSGS Investigative CenterLawrencevilleGeorgia30046-
FSGS Investigative CenterChicagoIllinois60611-
FSGS Investigative CenterIowa CityIowa52242-
FSGS Investigative CenterLouisvilleKentucky40202-
FSGS Investigative CenterShreveportLouisiana71101-
FSGS Investigative CenterDetroitMichigan48201-
FSGS Investigative CenterMinneapolisMinnesota55414-
FSGS Investigative CentreSt LouisMissouri63110-
FSGS Investigative CenterNewarkNew Jersey07103-
FSGS Investigative CenterNew YorkNew York10032-
FSGS Investigative CenterChapel HillNorth Carolina27599-7155-
FSGS Investigative CenterCharlotteNorth Carolina28204-
FSGS Investigative CenterColumbusOhio43210-
FSGS Investigative CenterBethlehemPennsylvania18017-
FSGS Investigative CenterDallasTexas75231-
FSGS Investigative CenterDallasTexas75246-
FSGS Investigative CenterEl PasoTexas79935-
FSGS Investigative CenterHoustonTexas77030-
FSGS Investigative SiteSalt Lake CityUtah84115-

Find similar trials in Denver, CO

By research site
FSGS Investigative Center· Denver, COFSGS Investigative Center· Winter Park, FLFSGS Investigative Center· Lawrenceville, GAFSGS Investigative Center· Chicago, ILFSGS Investigative Center· Iowa City, IAFSGS Investigative Center· Louisville, KY

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