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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
A.O. Ospedale Papa Giovanni XXIII

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Diseases Heart Transplantation Drug: Everolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
Study Start Date : January 2007
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: Everolimus
cyclosporine dose reduced of 50% after introduction of everolimus



Primary Outcome Measures :
  1. 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 :
  1. All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace [ Time Frame: 2 years ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505102


Locations
Italy
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
Investigators
Study Director: Roberto Fiocchi, MD PhD Heart Transplant Center Ospedali Riuniti Bergamo

Publications:
Responsible Party: Roberto Fiocchi, Ospedali Riuniti Bergamo
ClinicalTrials.gov Identifier: NCT00505102     History of Changes
Other Study ID Numbers: SAREFU123
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents