Safe Renal Function In Long Term Heart Transplanted Patients

Kidney Diseases Clinical Trial

— SAREFU  

Official title:

Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00505102
• Other study ID #: SAREFU123
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 19, 2007
• Last updated: February 12, 2008
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: February 2008
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Transplantation
• Kidney Diseases

Intervention

Drug:
• Everolimus
cyclosporine dose reduced of 50% after introduction of everolimus

Locations

Country	Name	City	State
Italy	Heart Transplant Center Ospedali Riuniti	Bergamo
Italy	Heart Transplantad Center OspedaliRiuniti Bergamo	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin		2 years	Yes
Secondary	All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace		2 years	Yes