Safe Renal Function In Long Term Heart Transplanted Patients (SAREFU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00505102
First received: July 19, 2007
Last updated: February 12, 2008
Last verified: February 2008

July 19, 2007
February 12, 2008
January 2007
July 2009   (final data collection date for primary outcome measure)
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Renal Function Evaluated Measuring Creatinine,Creatinine Clearance(MDRD and Cockcroft-Gault ) and Urinary excretion of Protein, albumin and alpha-1-microglobulin [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00505102 on ClinicalTrials.gov Archive Site
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure,Chronic Rejection, MACE [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Safe Renal Function In Long Term Heart Transplanted Patients
Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients

The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Diseases
  • Heart Transplantation
Drug: Everolimus
cyclosporine dose reduced of 50% after introduction of everolimus
Active Comparator: A
Intervention: Drug: Everolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Heart Transplant patients with more than 1 year of follow-up
  • Creatinine lower than 3.5 mg/dl
  • GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
  • Cyclosporine in maintenance immunosuppressive therapy
  • Patient must be able to sign an approve informed consent
  • Prior History of acute rejection within the last 3 months
  • Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used

Exclusion Criteria:

  • Patients who are recipients of multiple organ transplants
  • Prior or current use of sirolimus or everolimus
  • History of acute rejection within the last 6 months
  • Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
  • Patient not able to attend all follow-up evaluations
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00505102
SAREFU123
Yes
Roberto Fiocchi, Ospedali Riuniti Bergamo
A.O. Ospedale Papa Giovanni XXIII
Mario Negri Institute for Pharmacological Research
Study Director: Roberto Fiocchi, MD PhD Heart Transplant Center Ospedali Riuniti Bergamo
A.O. Ospedale Papa Giovanni XXIII
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP