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

• Status: Unknown status
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Tacrolimus

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.