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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.
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
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and evening, while in study--experimental group named Tacrolimus QD- Advagraf, the baseline tacrolimus BID will be withdrawn and replaced by Advagraf tacrolimus formulation which will be taken once daily in the morning.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 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.
The primary endpoint:
• adherence to the Tacrolimus administration defined as self-reported number of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire
• 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
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tacrolimus BID, Tacrolimus QD
Rabin Med Ctr
Not yet recruiting
Rabin Medical Center
Published on BioPortfolio: 2016-06-20T18:53:21-0400
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