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

Primary Purpose

Kidney Diseases, Heart Transplantation

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Everolimus
Sponsored by
A.O. Ospedale Papa Giovanni XXIII
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Transplant Center Ospedali Riuniti
  • Heart Transplantad Center OspedaliRiuniti Bergamo

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin

Secondary Outcome Measures

All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace

Full Information

First Posted
July 19, 2007
Last Updated
February 12, 2008
Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
Mario Negri Institute for Pharmacological Research
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1. Study Identification

Unique Protocol Identification Number
NCT00505102
Brief Title
Safe Renal Function In Long Term Heart Transplanted Patients
Acronym
SAREFU
Official Title
Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Heart Transplantation
Keywords
Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
cyclosporine dose reduced of 50% after introduction of everolimus
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Fiocchi, MD PhD
Organizational Affiliation
Heart Transplant Center Ospedali Riuniti Bergamo
Official's Role
Study Director
Facility Information:
Facility Name
Heart Transplant Center Ospedali Riuniti
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Heart Transplantad Center OspedaliRiuniti Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12954741
Citation
Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
Results Reference
background
PubMed Identifier
17346627
Citation
Rothenburger M, Teerling E, Bruch C, Lehmkuhl H, Suwelack B, Bara C, Wichter T, Hinder F, Schmid C, Stypmann J. Calcineurin inhibitor-free immunosuppression using everolimus (Certican) in maintenance heart transplant recipients: 6 months' follow-up. J Heart Lung Transplant. 2007 Mar;26(3):250-7. doi: 10.1016/j.healun.2007.01.017.
Results Reference
background

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Safe Renal Function In Long Term Heart Transplanted Patients

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