Status:
UNKNOWN
Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Astellas Pharma Taiwan, Inc.
Conditions:
Adherence to Medication Regime
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief 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 thi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02251691
Start Date
May 9 2014
End Date
March 31 2020
Last Update
April 2 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100