Shift to Everolimus (RAD) Kidney Sparing Study

This study has been terminated.

( A cluster of adverse events in everolimus arm was noted. We decided to perform a safety/efficacy interim analysis. )

First Received: January 9, 2007 Last Updated: May 1, 2009 History of Changes

Sponsored by:	University of Bologna
Information provided by:	University of Bologna
ClinicalTrials.gov Identifier:	NCT00420537

Purpose

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.

Condition	Intervention	Phase
Kidney Dysfunction Heart Transplantation	Drug: cyclosporine Drug: Mycophenolate mofetil Drug: Everolimus	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Low-Dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Everolimus

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:

Calculated GFR [ Time Frame: One year after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
mycophenolate: Active Comparator Mycophenolate mofetil with cyclosporine trough levels between 100 and 150	Drug: cyclosporine cyclosporine trough levels between 100 and 150 Drug: Mycophenolate mofetil mycophenolate with low doses
Everolimus: Active Comparator Everolimus with cyclosporine trough levels between 40 and 90 ng/ml	Drug: cyclosporine cyclosporine trough levels between 40 and 90 ng/ml Drug: Everolimus

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420537

Locations

Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138

Sponsors and Collaborators

University of Bologna

Investigators

Study Chair:

Angelo Branzi, MD

Alma Mater Studiorum University of Bologna

More Information

Publications:

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.

Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen 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.

Responsible Party:	University of Bologna ( University of Bologna )
Study ID Numbers:	2006-003035-78
Study First Received:	January 9, 2007
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00420537 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Bologna:

Kidney
Heart Transplantation
Creatinine
Glomerular Filtration Rate

Study placed in the following topic categories:

Everolimus
Anti-Infective Agents
Cyclosporine
Immunologic Factors
Antifungal Agents

Mycophenolate mofetil
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Everolimus
Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Mycophenolate mofetil
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 09, 2009