A PROSPECTIVE TRIAL , MONOCENTRIC, RANDOMIZED, TO EVALUATE THE RENAL'S FUNCTION IN SUBJECTS WITH CARDIAC TRANSPLANTED - SAVE RENAL FUNCTIO

• Conditions: CARDIAC-TRASPLATED; MedDRA version: 9.1Level: LLTClassification code 10048870Term: Prophylaxis against transplant rejection

• Registration Number: EUCTR2006-002786-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-07
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.