A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf (NCT01265537) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
Canada30 participantsStarted 2011-06-24
Plain-language summary
While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant
✓. No history of pre-existing diabetes mellitus
✓. Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation
✓. Random plasma glucose level \<11.1 at the time of transplantation
✓. Peak PRA (panel reactive antibody) \<30%
✓. Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
✓. The patient has given written informed consent to participate in the study
Exclusion criteria
✕. Patients with primary non-function
✕. Peak PRA\>=30%
What they're measuring
1
Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection