Skip to main content
OpenTrials
Completed

NCT Number: NCT00097968

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graft Rejection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCLA Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus

Drug

Primary outcomes

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

Secondary outcomes

  1. Major Adverse Cardiac Events at 3 and 6 months.

  2. Patient survival at 3 and 6 months.

  3. Treated acute rejection at 3 and 6 months.

  4. Admission to the hospital at 3 and 6 months.

  5. Premature study treatment discontinuation at 3 and 6 months.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
First posted
Dec 2, 2004
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.