Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy

Phase 3

Completed

• Conditions: Graft Rejection

• Registration Number: NCT00097968
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Primary Completion: 2005-04
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.
• Patient must be on statins at study entry.
• Patient who is more than 12 months post-transplant.

Exclusion Criteria

• Patient with a serum creatinine value >2.0 mg/dL.
• Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months prior to study entry.
• Patient who had received any investigational drug within 4 weeks prior to study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Midstate Cardiology; 🇺🇸 Nashville, Tennessee, United States

University of Minnesota, Fairfield University Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States