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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505102

Locations
Italy
Heart Transplantad Center OspedaliRiuniti Bergamo
Bergamo, Italy, 24100
Heart Transplant Center Ospedali Riuniti
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
  More Information

Publications:
Responsible Party: Roberto Fiocchi, Ospedali Riuniti Bergamo
ClinicalTrials.gov Identifier: NCT00505102     History of Changes
Other Study ID Numbers: SAREFU123
Study First Received: July 19, 2007
Last Updated: February 12, 2008
Health Authority: Italy: National Institute of Health

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014