Safe Renal Function In Long Term Heart Transplanted Patients - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Ospedali Riuniti di Bergamo Mario Negri Institute for Pharmacological Research
Information provided by:	Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:	NCT00505102

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 IV

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Cyclosporin Cyclosporine Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients

Further study details as provided by Ospedali Riuniti di Bergamo:

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
A: Active Comparator	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

Ospedali Riuniti di Bergamo

Mario Negri Institute for Pharmacological Research

Investigators

Study Director:

Roberto Fiocchi, MD PhD

Heart Transplant Center Ospedali Riuniti Bergamo

More Information

Publications:

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.

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.

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

Keywords provided by Ospedali Riuniti di Bergamo:

Kidney Diseases
Heart Transplantation
Everolimus
Cyclosporine Toxicity

Study placed in the following topic categories:

Everolimus
Cyclosporine
Urologic Diseases
Kidney Diseases
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009