Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT00270634
Phase
PHASE2
Status
Completed

Conditions

  • Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin — DRUG
    voclosporin 0.4, 0.6, 0.8 mg/kg po BID
  • tacrolimus — DRUG
    tacrolimus 0.05 mg/kg po BID

Study Details

This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Key Dates

Start date
Jan 31, 2006
Status verified
Feb 2013
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

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

Arms

  • Active Comparator: Low Dose Voclosporin
    Low dose voclosporin
  • Active Comparator: Mid Dose Voclosporin
    Mid Dose Voclosporin
  • Active Comparator: High Dose Voclosporin
    High Dose Voclosporin
  • Active Comparator: Tacrolimus
    Standard Dose Tacrolimus

Primary Outcome Measure

Biopsy Proven Acute Rejection (BPAR) [ Time Frame: Six months ]

Locations (40)

FacilityCityStateZIPSite coordinators
Isotechnika Investigational SiteBirminghamAlabama35924-
Isotechnika Investigational SiteLos AngelesCalifornia90033-
Isotechnika Investigational SiteLos AngelesCalifornia90057-
Isotechnika Investigational SiteLos AngelesCalifornia90095-7306-
Isotechnika Investigational SiteOrangeCalifornia92868-
Isotechnika Investigational SitePalo AltoCalifornia94304-1510-
Isotechnika Investigational SiteSan DiegoCalifornia92123-
Isotechnika Investigational SiteSan FranciscoCalifornia94143-0116-
Isotechnika Investigational SiteDenverColorado80262-
Isotechnika Investigational SiteGainesvilleFlorida32610-
Isotechnika Investigational SiteTampaFlorida33606-
Isotechnika Investigational SiteChicagoIllinois60611-
Isotechnika Investigational SiteChicagoIllinois60637-
Isotechnika Investigational SiteLexingtonKentucky40536-
Isotechnika Investigational SiteNew OrleansLouisiana70112-
Isotechnika Investigational SiteNew OrleansLouisiana70121-
Isotechnika Investigational SiteBaltimoreMaryland21201-
Isotechnika Investigational SiteBostonMassachusetts02215-
Isotechnika Investigational SiteAnn ArborMichigan48109-9623-
Isotechnika Investigational SiteDetroitMichigan48202-
Isotechnika Investigational SiteRochesterMinnesota55905-
Isotechnika Investigational SiteLivingstonNew Jersey07039-
Isotechnika Investigational SiteBuffaloNew York14203-
Isotechnika Investigational SiteHawthorneNew York10532-
Isotechnika Investigational SiteNew YorkNew York10021-
Isotechnika Investigational SiteRochesterNew York14642-8410-
Isotechnika Investigational SiteDurhamNorth Carolina27705-
Isotechnika Investigational SiteWinston-SalemNorth Carolina27157-
Isotechnika Investigational SiteCincinnatiOhio45219-
Isotechnika Investigational SiteCincinnatiOhio45267-0585-
Isotechnika Investigational SitePortlandOregon97210-
Isotechnika Investigational SitePortlandOregon97239-2940-
Isotechnika Investigational SitePortlandOregon97329-2940-
Isotechnika Investigational SitePhiladelphiaPennsylvania19102-
Isotechnika Investigational SitePhiladelphiaPennsylvania19104-
Isotechnika Investigational SiteCharlestonSouth Carolina29425-
Isotechnika Investigational SiteMemphisTennessee38104-
Isotechnika Investigational SiteDallasTexas75246-
Isotechnika Investigational SiteHoustonTexas77030-
Isotechnika Investigational SiteRichmondVirginia23298-

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Isotechnika Investigational Site· Birmingham, ALIsotechnika Investigational Site· Los Angeles, CAIsotechnika Investigational Site· Orange, CAIsotechnika Investigational Site· Palo Alto, CAIsotechnika Investigational Site· San Diego, CAIsotechnika Investigational Site· San Francisco, CA

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