Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00097968|
Recruitment Status : Completed
First Posted : December 2, 2004
Last Update Posted : July 12, 2010
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation.
It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.
|Condition or disease||Intervention/treatment||Phase|
|Graft Rejection||Drug: everolimus||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||April 2005|
- Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
- Major Adverse Cardiac Events at 3 and 6 months.
- Patient survival at 3 and 6 months.
- Treated acute rejection at 3 and 6 months.
- Admission to the hospital at 3 and 6 months.
- Premature study treatment discontinuation at 3 and 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097968
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|United States, Minnesota|
|University of Minnesota, Fairfield University Hospital|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Richard Dorent, MD||Novartis Pharmaceuticals|