Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus (Advagraf)
|ClinicalTrials.gov Identifier: NCT02805842|
Recruitment Status : Unknown
Verified July 2016 by Alexander yussim, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 20, 2016
Last Update Posted : July 12, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Drug: Tacrolimus BID Drug: Advagraf QD||Phase 3|
Following randomization (Day 0), 60 kidney transplant recipients of deceased or live kidneys will be randomized 1:2 into control and study- experimental arm. In control arm, named Tacrolimus BID arm, tacrolimus will be administered unchanged twice daily, morning and evening, while in study--experimental group named Tacrolimus QD- Advagraf, the Advagraf tacrolimus formulation will be administered 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 6-8 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus (ADVAGRAF) in Kidney Transplant Recipients|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: Tacrolimus BID
20 patients receiving twice daily (BID) Tacrolimus
Drug: Tacrolimus BID
Administration of Tacrolimus BID
Other Name: Prograf, Tacrocell
Active Comparator: Advagraf QD
40 patients randomized to receive once daily (QD) Advagraf
Drug: Advagraf QD
administration of Advagraf QD
Other Name: Advagraf
- Morisky Medical Adherence Assessment questionnaire [ Time Frame: 2 years ]adherence to the Tacrolimus QD administration defined as self-reported number 9on scale from 1-8) of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire
- graft and patient survival [ Time Frame: 2 years ]% of patients and grafts alive after 1st and 2nd year of study
- gfr [ Time Frame: 2 years ]gfr - glomerular filtration rate - a measure of renal function, in ml/min/1.73m2
- adverse events [ Time Frame: 2years ]percentage of patients with complications
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805842
|Contact: Eytan Mor, MDfirstname.lastname@example.org|
|Contact: Alex Yussim, MDemail@example.com|
|Rabin Med Ctr|
|Petach Tikva, Israel, 4100|
|Study Director:||Eyan Mor, MD||Rabin Med CTR|