Tocilizumab for Renal Graft Inflammation (NCT02108600) | Clinical Trial Compass
CompletedPhase 2
Tocilizumab for Renal Graft Inflammation
United States33 participantsStarted 2014-06
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All kidney transplant recipients with SCI on 6-month surveillance biopsy.
* Maintenance immunosuppression regimens containing tacrolimus and MMF with or without prednisone.
* Ability to provide written informed consent for the study.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
Exclusion Criteria:
General:
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
Excluded Previous or Concomitant Therapy:
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
* Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20, except Thymoglobulin.
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
* Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
* Previous treatment with TCZ (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis).
* Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
Exclusions for General Safety:
* Presence of acut…
What they're measuring
1
Change in Inflammation on Renal Allograft Biopsy From Baseline to 6 Months