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

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ClinicalTrials.gov Identifier: NCT00505102
Recruitment Status : Unknown
Verified February 2008 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2007
Last Update Posted : February 13, 2008
Information provided by:

July 19, 2007
July 20, 2007
February 13, 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 ]
Same as current
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 ]
Same as current
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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Unknown status
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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