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Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations

NCT02402140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2015-11-03

No results posted yet for this study

Summary

Primary end-point

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.

Secondary end-points

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 transplant;
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 as nonadherent;
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.

Study Design

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.

Conditions

  • Renal Transplant Graft Failure

Interventions

OTHER

Pharmaceutical Intervention

Patients allocated to group 1, with pharmaceutical intervention, received instructions on the proper use of immunosuppressants as doses, frequency, importance, schedules on the following days 3, 5, 7, 10, 14, 21, 28, 60 and 90 after kidney transplant. Teaching materials were designed to assist in the pharmaceutical guidelines that understood the importance of immunosuppressive drugs, the risk of rejection, the schedules and the most appropriate way for the administration. In addition to these guidelines, pharmacists helped patients in filling out the patient diary. This diary contains all the medications that the patient administers and encourages them to write down daily doses in order to remind them. This was a standardized pharmacist intervention.

Sponsors & Collaborators

  • Hospital do Rim e Hipertensão

    lead OTHER

Principal Investigators

  • Adrieli BA Bessa, Pharmacist · Hospital do Rim

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-10-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402140 on ClinicalTrials.gov