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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Active, not recruiting
Mario Negri Institute for Pharmacological Research
Information provided by:
A.O. Ospedale Papa Giovanni XXIII Identifier:
First received: July 19, 2007
Last updated: February 12, 2008
Last verified: February 2008
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

Condition Intervention Phase
Kidney Diseases
Heart Transplantation
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients

Resource links provided by NLM:

Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace [ Time Frame: 2 years ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Everolimus
cyclosporine dose reduced of 50% after introduction of everolimus


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00505102

Heart Transplant Center Ospedali Riuniti
Bergamo, Italy, 24100
Heart Transplantad Center OspedaliRiuniti Bergamo
Bergamo, Italy, 24100
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Mario Negri Institute for Pharmacological Research
Study Director: Roberto Fiocchi, MD PhD Heart Transplant Center Ospedali Riuniti Bergamo
  More Information

Responsible Party: Roberto Fiocchi, Ospedali Riuniti Bergamo Identifier: NCT00505102     History of Changes
Other Study ID Numbers: SAREFU123
Study First Received: July 19, 2007
Last Updated: February 12, 2008

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Kidney Diseases
Heart Transplantation
Cyclosporine Toxicity

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 28, 2017