Evaluating the safety and efficacy of mycophenolate mofetil, daclizumab and a single, initial week of corticosteroids in combination with tacrolimus or sirolimus with continued steroid as mainstay immunosuppression in comparison to current standard immunosuppression (mycophenolate mofetil, tacrolimus and continued corticosteroids) in renal transplantation. - UK ELiTE

Barts and the London NHS Trust0 sites0 target enrollmentFebruary 15, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2005

End Date

February 10, 2005

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Barts and the London NHS Trust

•The enrolled patients must fulfill the following inclusion criteria:
•1\.Male and female patients between 18 and 75 years of age
•2\.Patients scheduled for a single\-organ, renal transplantation from living or cadaver donors. Patient receiving second renal transplants can be included, provided that the previous graft was not lost from acute rejection within the first year.
•3\.Patients capable of understanding the purposes and risks of the study, who give written informed consent and who are willing to participate to and comply with the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•The following groups of patients will not be included in the study:
•1\.Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the drugs administered within this clinical study.
•2\.Patients receiving the third or higher renal transplant.
•3\.Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
•4\.Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
•5\.Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs\-Ag positive) or C.
•6\.Patients with history of malignancy (except successfully treated localized non\-melanocitic skin cancer).
•7\.Patients with active peptic ulcer disease.
•8\.Patients with evidence of an active liver disease
•9\.Patients with severe anemia (Hb\<6 g/dl) leucopenia (WBC\<2500/mm3\), thrombocytopenia (Tc \<100’000/mm3\)