Tocilizumab for Renal Graft Inflammation

Part of paid clinical trials in San Francisco, California.

Sponsor
Flavio Vincenti
Study ID
NCT02108600
Phase
PHASE2
Status
Completed

Conditions

  • Late Complication From Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.

Study Details

Randomized open label clinical trial in which 48 renal transplant recipients with inflammation in the 6 month allograft biopsy will either continue usual immunosuppression or receive monthly Actemra (Tocilizumab) infusions for 6 months in addition to usual immunosuppression.

Key Dates

Start date
Jun 30, 2014
Status verified
Mar 2021
Primary completion
Dec 16, 2018
Completion
Dec 16, 2018

Study Design

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

Arms

  • No Intervention: Standard of Care
    Will continue usual immunosuppression and not receive any specific intervention.
  • Experimental: Tocilizumab (TCZ) Group
    Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.

Primary Outcome Measure

Change in Inflammation on Renal Allograft Biopsy From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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University of California, San Francisco· San Francisco, CA