Shift to Everolimus (RAD) Kidney Sparing Study

Heart Transplantation Clinical Trial

Official title:

Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420537
• Other study ID #: 2006-003035-78
• Status: Terminated
• Phase: Phase 4
• First received: January 9, 2007
• Last updated: January 11, 2010
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart Transplant with 1 to 4 years of follow-up

• GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

Exclusion Criteria:

• Acute rejection in the previous 6 months

• Contraindications to statin therapy

• Ongoing infection

• Ongoing heart failure

• Myocardial infarction or myocardial revascularization after transplant

• Malignancy

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 Dysfunction

Intervention

Drug:
• cyclosporine
cyclosporine trough levels between 100 and 150
• cyclosporine
cyclosporine trough levels between 40 and 90 ng/ml
• Mycophenolate mofetil
mycophenolate with low doses
• Everolimus

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sørensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. — View Citation

Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated GFR		One year after randomization	Yes