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

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborators: Astellas Pharma Inc; Teva Pharma
• Treatments: Tacrolimus

Criteria

Inclusion Criteria

• Age: 18 Years to 60 Years

• Gender: both

• Patients willing and able to participate in this study

• Patients who signed the informed consent form

• Patients who can visit the center based on the study schedule in the protocol

Exclusion Criteria

• Patients who had previously received a kidney or another organ

• Patients, having positive lymphocyte cross-match

• Patients with PRA >50%

• Patients, who underwent desensitization

• Patients, who were diagnosed with cancer in the last five years

• Patients, who themselves or their donors have positive HIV, HBsAg, or anti-HCV test results

• Patients, who were treated with other investigated drugs within 30 days from their study enrollment

• Patients, who are planning to be pregnant, or who are pregnant or breastfeeding and who are not planning to use any contraceptive method during the study period.

• Patients who were addicted to drugs/alcohol within six months of their study enrollment

• Patients, who have a mental illness that makes appropriate communication with them impossible