Multicenter, no-profit, open, single sequence cross-over study on effectiveness and safety of anti-rejection therapy based on modified release Tacrolimus(Advagraf)and on patients quality of life and adhesion to therapeutical regimen improvement after switch from conventional BID(Prograf) Tacrolimus immunosuppressive therapy to mono-administration of modified release of Tacrolimus in stable kidney transplant recipient - ND
- Conditions
- Kidney transplant patientsMedDRA version: 9.1Level: PTClassification code 10023439
- Registration Number
- EUCTR2010-019086-28-IT
- Lead Sponsor
- O Divisione Nefrologia, Dialisi e Trapianto renale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. both gender older than 18 years 2. one year kidney transplant 3.Prograf dosage unchanged in last 12 weeks before enrollement 4. Tacrolimus ematic levels stable within 5-15 ng/ml in last 12 weeks before enrollement 5.immunosuppressive regimen unchanged in last 12 weeks before enrollement 6. women in fertile ages with pregnancy test negative (performed in serum) with willing of using contraceptive methods all time study long 7. clinically stable patientsaccording to investigator opinion 8. patients capable of understanding and will, able to understand aims and risks of experimentation, who have signed informed consent at study enrollement
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
1. graft different from kidney 2. acute rejection episode within 12 weeks before enrollement or acute rejection episode within 24 weeks before enrollement, who required anti-lymphocity treatment 3. new onset malignat neoplasia after transplant 4. known allergy or hypersensitivity to one or both drugs components uesd in study 5. clinically unstable patients 6. history of drugs abuse or psychiatric issues which in investigator opinion could get difficolt patient-investigator comunication 7. patinets enrolled in an other clinical study 8. patients who have used or are using drugs non lcenesed in protocoll 9. pregnant or breastfeeding women 10.HIV positive pateints 11. patients who according to investigator opinion are not able to obey dadeline and procedures of protocol 12.proteinuria more than 2 g/24h 13. creatinine clearance mesured by Cockcroft-Gault formula < 40 ml/min 14. sieric creatinine levels increased more than 20% in last 6 mouths before enrollement 15. GOT GPT increased or bilirubin level increased two times of normal range 16. Hepatic cyrrosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison between Advagraf and Prograf of adherence index to the therapy with tacrolimus by patients who had an allogenic renal transplanation and who showed steadiness of hematic levels of tacrolimus. The dosage method will be the same for all centres taking part in the study.;Secondary Objective: To ass safety and effectivenessof anti-rejection therapy based on modified release Tacrolimus(Advagraf)in stable kidney transplant recipient after switch from conventional Tacrolimus BID therapy;Primary end point(s): Stability of plamsatic level of Tacrolimus after switch to Advagraf. Stability of renal function parameters (serum creatinine, creatinine clearance misured, azotemia)after switch to Advagraf. Improvement of adhesion and comfort to therapy by patients, assessed by test
- Secondary Outcome Measures
Name Time Method