Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations

NCT02402140 | Completed

• 1 other identifier: Hospital do Rim
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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. 4.We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);
5. 5.We evaluated Incidence of Infections;
6. 6.We evaluated Treated acute rejection episodes;
7. 7.We evaluated Death cases;
8. 8.We evaluated Graft loss cases;
9. 9.We evaluated Discontinuation of immunosuppressive treatment;
10. 10.We evaluated Hospital readmissions.

Conditions

Renal Transplant Graft Failure

Keywords

tacrolimus blood concentration; pharmaceutical intervention; intrasubject variability

Outcome Measures

Primary Outcomes (1)

• The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation.

  Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= SD x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.

  3 months

Secondary Outcomes (10)

• Assess patient adherence through validated questionnaire "Portuguese version of BAASIS scale (Basel Scale Adherence Rating Immunosuppressive Drugs)";

  3 months

• Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits day 7, 10, 14, 21, 28, 60 e 90 post kidney transplant

  3 months

• We also evaluated renal function (eGFR by MDRD formula)

  3 months

• Tacrolimus bioavailability profile during the period of 3 months

  3 months

• We evaluated the incidence of Infections

  3 months

Study Arms (2)

1 with pharmaceutical intervention

EXPERIMENTAL

Patients allocated to group 1 with pharmaceutical intervention received instructions on the proper use of immunosuppressants as dosage, frequency and administration schedules, importance of immunosuppressive drugs and the risk of rejection. No more interventions were applied.

Other: Pharmaceutical Intervention

2 without pharmaceutical intervention

NO INTERVENTION

Standard following of the Hospital do Rim, without pharmaceutical intervention. This group was just followed by the nurses of the hospital, but without a standardized intervention. It was not a intervention, it was the control group

Interventions

Pharmaceutical Intervention OTHER

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.

1 with pharmaceutical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who underwent renal transplantation aged ≥18 years old,
• who signed the informed consent,
• who underwent follow-up post transplant clinic at the Hospital do Rim for 3 months,
• receiving immunosuppressive drugs tacrolimus, prednisone and sodium mycophenolate or tacrolimus, azathioprine, and prednisone.

You may not qualify if:

• were patients who underwent second kidney transplant,
• which did not follow the Hospital do Rim after transplant and who were participating in some other study with pharmaceutical intervention.

Sponsors & Collaborators

• Hospital do Rim e Hipertensão: lead

Related Publications (1)

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

  PMID: 36094829 DERIVED

Study Officials

• Adrieli BA Bessa, Pharmacist

  Hospital do Rim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 30, 2015
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-10