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

Graft Rejection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097968
• Other study ID #: CRAD001A2405
• Secondary ID: RAD/Certican
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2004
• Last updated: July 9, 2010
• Start date: August 2004

Study information

• Verified date: July 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft Rejection

Intervention

Drug:
• everolimus

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	UCLA Medical Center	Los Angeles	California
United States	University of Minnesota, Fairfield University Hospital	Minneapolis	Minnesota
United States	Midstate Cardiology	Nashville	Tennessee
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Secondary	Major Adverse Cardiac Events at 3 and 6 months.
Secondary	Patient survival at 3 and 6 months.
Secondary	Treated acute rejection at 3 and 6 months.
Secondary	Admission to the hospital at 3 and 6 months.
Secondary	Premature study treatment discontinuation at 3 and 6 months.