CARDIAC-TRASPLATED MedDRA version: 9.1 Level: LLT Classification code 10048870 Term: Prophylaxis against transplant rejection
Conditions
Interventions
Trade Name: CERTICAN*60CPS 0,25MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .25-
Trade Name: SAND
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AGE>18 YEARS CARDIAC TRANSPLANT IMMUNOTHERAPHY WHIT CICLOSPORINE INFORMED CONSENT 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.A DIFFERENT TRASPLANT 2.TREATMENT WITH MTOR'S INIBHITOR FOR PREVIOUS THREE MONTH 3.ACUTE REJECTION 6MONTH AGO 4. BY PASS 5. WOMEN, IN FERTILE AGE, WITHOUT ADAPT TO YOU AVERAGE OF PREVENTION OF AN EVENTUAL PREGNANCY 6.IT COUNTS PIASTRINICA < 50000/MM. 7. PROTEINURIA  1 G/24 HOURS. 8. FILTRATION GLOMERULARE < 20 ML/MIN. 9. EPISODE OF ACUTE REFUSAL IN THE 6 MONTHS PREVIOUS TO THE RANDOMIZZAZIONE. 10. CARDIAC PARTICIPATION OR BY-PASS AORTO-CORONARICO In the ORGAN TRANSPLANTED IN the 3 MONTHS PREVIOUS TO the RANDOMIZZAZIONE. 11. PATIENT IN ATTENDED LIST Of FOR a NEW TRANSPLANT. 12. PATIENT NOT IN A POSITION TO FOLLOWING THE PRESCRIBED THERAPEUTIC REGIMEN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE EFFICACY OF EVEROLIMUS AND LOW DOSES OF CICLOSPORINE CAN INVOLVE AN IMPROVEMENT OF THE RENAL FUNCTIONALITY OR A SLOWING DOWN OF THE PROGRESSION TOWARDS THE RENAL INSUFFICIENCY FINISHES;Secondary Objective: ///;Primary end point(s): IMPROVEMENT OF THE ESTIMATED RENAL FUNCTIONALITY WITH CREATININA, CLEARANCE OF CREATININA (COCKROFT-GAULT), CREATINURIA AND PROTEINURIA. | — |
Countries
Italy
Outcome results
None listed