SAREFU: Safe Renal Function In Long Term Heart Transplanted Patients
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A
|
Drug: Everolimus
cyclosporine dose reduced of 50% after introduction of everolimus
|
Outcome Measures
Primary Outcome Measures
- Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin [2 years]
Secondary Outcome Measures
- All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace [2 years]
Eligibility Criteria
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
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Patient must be able to sign an approve informed consent
-
Prior History of acute rejection within the last 3 months
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Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used
Exclusion Criteria:
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Patients who are recipients of multiple organ transplants
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Prior or current use of sirolimus or everolimus
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History of acute rejection within the last 6 months
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Transplant Center Ospedali Riuniti | Bergamo | Italy | 24100 | |
| 2 | 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
Study Documents (Full-Text)
None provided.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.
- SAREFU123