Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant

The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.

The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation recipients base on the assumption that once-daily dosing regimen may help to improve drug compliance.

This study will be a prospective, two-arm randomized and open-label, phase IV study to compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus standard twice-daily tacrolimus based regimen after de novo renal transplantation.

The investigators will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)

Eligibility Criteria:
Male and female adult patients who are to receive renal transplantation may enter the study. The intention is to enroll 90 patients who have fulfilled inclusion/exclusion criteria into the study. Sixty patients will receive prolonged-release once-daily tacrolimus based therapy; the other thirty patients will receive standard twice-daily tacrolimus based therapy.

Inclusion criteria

* Male or female patients at 20-65 years of age undergoing renal transplantation
* Patients who have been informed of the potential risks and side effects of the study
* Female patients of childbearing potential must agree to maintain effective birth control during the study.
* Patients have been fully informed and have given written informed consent to participate in the study

Exclusion criteria

* Donor age greater than 65 years
* Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)
* Patients who are recipients of multiple solid organ transplants
* Patients undergoing second or subsequent transplantation
* Patients with pre-transplant PRA \> 20%
* Patients with ABO incompatibility or positive lymphocytotoxicity
* Patients with severe, active infection
* Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or total bilirubin \>3 times the upper normal limit
* Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive
* Patients who have been treated with an investigational drug or therapy within one month prior to entry or who will be so treated within 6 months of transplantation
* Patients with a history of malignancy within the last five years except excised squamous or basal cell carcinoma
* Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to comply fully with the study requirements.
* Patients who require on-going dosing with a systemic immunosuppressive drugs prior to transplantation.
* Pregnant woman or breast-feeding mother during the period of this study.
* Patients who are allergy to tacrolimus, macrolide antibiotics, steroid or mycophenolate mofetil.