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Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus

2016-06-20 18:53:21 | BioPortfolio

Summary

Aim The primary objective of this study is to compare medication adherence with medical therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.

Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and once-daily tacrolimus groups

Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily regimens, measured in terms of implementation. Secondary outcomes will include graft and patient survival, renal function and adverse events. Follow up - 12 months

Description

Following transplantation (Day 0), all 60 patients (named Tacrolimus baseline arm) will receive Tacrolimus BID in combination with MMF and corticosteroids.

A preoperative tacrolimus dose, 0.1 mg/kg , administered orally at any time of day, will be given prior to surgery. The initial postoperative tacrolimus dose will be 0.1 mg/kg/day. On day 30 after the enrollment the patients will be randomized 1:2 into control and study- experimental arm. In control arm, named Tacrolimus BID arm, tacrolimus will be continued unchanged from the baseline twice daily, morning and evening, while in study--experimental group named Tacrolimus QD- Advagraf, the baseline tacrolimus BID will be withdrawn and replaced by Advagraf tacrolimus formulation which will be taken once daily in the morning. In both groups doses will be adjusted to maintain tacrolimus trough levels at 10-12 ng/mL (days 1-28), 8-10 ng/mL (days 29-168) and 6-10 ng/mL thereafter for both treatment arms.

Adjunct immunosuppression. Per-protocol rejection prophylaxis: All patients will receive Basiliximab induction at 20mg/bw on days 0 and 4. Methylprednisolone will be administered as intravenous bolus doses of 500 mg , 250 mg and 125 mg perioperatively, on days 0,1 and 2. Thereafter oral prednisone will be given: 20 mg/day (days 2-14), 15 mg/day (days 15-30), 10 mg/day (days 30-45), 7.5 mg/day (days 45-60) and 5 mg/day thereafter. MMF (2 g BID) will be started preoperatively, and reduced to 500 mg three times daily after 14-30 days.

Rejection treatment: First-line acute rejection (AR) therapy with corticosteroids will be administered at the dose of 500 mg/day for 3 days. Mono- and/or polyclonal antibodies could be used as therapy for corticosteroid-resistant AR. First-line antibody therapy will be permitted only if biopsy indicate a severe vascular rejection (Banff IIB or III).

Prophylactic treatment:

Prophylactic antiviral treatment with oral ganciclovir 450 mg/day, and PCP prevention with 400 mg Sulfamethoxazole and 80 mg of Trimethoprim/day will be given to all patients on days 1-90.

Endpoints.

The primary endpoint:

• adherence to the Tacrolimus administration defined as self-reported number of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire

Secondary endpoints:

• efficacy failure defined as biopsy proven rejection, renal function, incidence of adverse events (AEs) and graft loss or death at the end of the analysis period

Statistical analysis The data collected will be analyzed with Fisher's exact test, Wilcoxon' matched pair test and Kaplan-Meier's test

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Medication Adherence

Intervention

Tacrolimus BID, Tacrolimus QD

Location

Rabin Med Ctr
Petach Tikva
Israel
4100

Status

Not yet recruiting

Source

Rabin Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-20T18:53:21-0400

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Medical and Biotech [MESH] Definitions

A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.

A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-

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