evaluation of the compliance to immunosoppressive therapy in transplatation recipient.

Phase 1

Conditions: Patients who underwent liver or renal transplantation
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2011-001995-20-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI PADOVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 408

Inclusion Criteria

1. Aging more than 18 2.Liver or renal transplantation from at least 8 months 3. immunosuppressive regimen with tacrolimus bid (Prograf) which hasn`t been changed in the last 2 months before the enrolment and without counterindications for switch to monotherapy (Advagraf). 4. Clinically stable patients 5. Childbearing potential female patients with negative serum pregnancy test who agree in using medical acceptable contraception for the whole duration of the study. 6. Patients who are able to give their consent 7. AST and ALT < 2 UNV (for liver transpantation) 8. Tacrolimus blood levels between 3-10 ng/ml and stable Prograf dosage in the 4-week period berfore enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

Exclusion Criteria

1. Acute rejection episodes in the 6-month period before enrolment. 2. Known allergy or hypersensibility to one or more investigational drugs components. 3. Any substances abuse, psychiatric disorders or any condition that, in investigator`s opinion, might affect the comunication with investigators or might affect the compliance to the study. 4. Newly diagnosed neoplasy after transplantation (excepted skin neoplasy)- 5. Patient participating in other clinical trial or who ended another clinical trial in the last 3 monts. 6. patients who took any other experimental drug in the month before the enrolment. 7. HIV positive patients 8. pregnant women 9. creatinine<30ml/min calculated by the Cockcroft and Gault`s formula (renal transpantation) 10. Increase of creatinine level over 20% in the last 6 months before enrolment (renal transplantation) 11. ASL/ALT > 2 UNV and/or total bilirubine >= 2 UNV (liver transplantation)