The primary end-point was the influence of pharmaceutical intervention in tacrolimus
intra-subject variability during the first 3 months after kidney transplant. Coefficients of
variation were calculated from the average of dose-corrected tacrolimus blood
concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60
and 90 post kidney transplant.
1. Secondary outcomes included evaluate percentage of patients who achieved target levels
of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney
2. Tacrolimus bioavailability profile during the period of 3 months,characterized by mean
and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);
3. Assess patient adherence through validated questionnaire "Portuguese version of Basel
Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale". It consists of a
four-item questionnaire measuring nonadherence to immunosuppressives over the past four
weeks. This questionnaire assesses omission of single doses or successive doses, timing
deviations >2h and dose reductions. Responses are given on a six-point scale: never,
once per month, every second week, every week, more than once per week and every day.
Patients that answer different from "never" in any of the four questions are considered
4. We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);
5. We evaluated Incidence of Infections;
6. We evaluated Treated acute rejection episodes;
7. We evaluated Death cases;
8. We evaluated Graft loss cases;
9. We evaluated Discontinuation of immunosuppressive treatment;
10. We evaluated Hospital readmissions.
This was a single-center, prospective, randomized and controlled study to evaluate the
influence of pharmaceutical intervention in tacrolimus intra-subject variability during the
first 3 months after transplantation. The authors designed the protocol, acquired and
maintained the data, and conducted the statistical analysis. The protocol was approved by an
independent ethics committee. All subjects signed a written informed consent before
enrollment and the study was conducted according to good clinical practices and declaration
of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December
2014, 128 randomized and were followed for 3 months after transplantation.