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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00097968
First received: December 1, 2004
Last updated: July 9, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Graft Rejection
Drug: everolimus
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.

Secondary Outcome Measures:
  • 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.

Study Start Date: August 2004
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097968

Locations
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
Midstate Cardiology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Richard Dorent, MD Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00097968     History of Changes
Other Study ID Numbers: CRAD001A2405, RAD/Certican
Study First Received: December 1, 2004
Last Updated: July 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
transplant, heart, adult, everolimus
allograft rejection

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014