evaluation of the compliance to immunosoppressive therapy in transplatation recipient.

A pilot study on educational aproach to improve compliance to medical precriptions in transplantation recipients. - Single

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001995-20-IT

Enrollment

408

Registered

2012-04-10

Start date

2011-03-14

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who underwent liver or renal transplantation

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical Form: Prolong

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 104

Exclusion criteria

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 2 UNV and/or total bilirubine >= 2 UNV (liver transplantation)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objecive is splitted in evaluated by the connection between two parts: - Efficacy of the switch from double to single daily administration of the immunosuppressant drug (from Progrf to Advagraf)to reduce the non compliant patient's population. - Efficacy of Self Learning anc Patient's education to reduce the non compliant patient's population;Secondary Objective: The secondary objective is the evaluation of the patient's perception, measured by objective and subjective paramethers, of his quality of life.;Primary end point(s): The primary endpoint is the compliance to medical prescriptions, defined as the complete cocperation of the patient in the therapy, attend to the scheduled visits, perform blood exams and comply with the healthy way of life as indicated by the investigator.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The main objecive is splitted in evaluated by the connection between two parts: - Efficacy of the switch from double to single daily administration of the immunosuppressant drug (from Progrf to Advagraf)to reduce the non compliant patient's population. - Efficacy of Self Learning anc Patient's education to reduce the non compliant patient's population;Secondary Objective: The secondary objective is the evaluation of the patient's perception, measured by objective and subjective paramethers, of his quality of life.;Primary end point(s): The primary endpoint is the compliance to medical prescriptions, defined as the complete cocperation of the patient in the therapy, attend to the scheduled visits, perform blood exams and comply with the healthy way of life as indicated by the investigator.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Italy

Contacts

Public ContactCRO

Hippocrates Research

REGULATORY.AIFA@HIPPOCRATES-RESEARCH.IT010 545481

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026