Safe Renal Function In Long Term Heart Transplanted Patients
SAREFU
Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
1 other identifier
interventional
200
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFebruary 13, 2008
February 1, 2008
2.5 years
July 19, 2007
February 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
2 years
Secondary Outcomes (1)
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace
2 years
Study Arms (1)
A
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Heart Transplant Center Ospedali Riuniti
Bergamo, 24100, Italy
Heart Transplantad Center OspedaliRiuniti Bergamo
Bergamo, 24100, Italy
Related Publications (2)
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.
PMID: 12954741BACKGROUNDRothenburger 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.
PMID: 17346627BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roberto Fiocchi, MD PhD
Heart Transplant Center Ospedali Riuniti Bergamo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 20, 2007
Study Start
January 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 13, 2008
Record last verified: 2008-02