CClinicalTrials.gg
Sign In
CompletedNCT00097968Updated Jul 12, 2010

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

A Phase 3 interventional study of everolimus in Graft Rejection, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Graft Rejection

Browse trials for

Keywords

  • transplant, heart, adult, everolimus
  • allograft rejection
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

Browse Vascular Diseases studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drugeverolimus
06

What researchers measure

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.

07

Study locations

6 sites
  • UCLA Medical Center
    Los Angeles, California 90095, United States
  • University of Minnesota, Fairfield University Hospital
    Minneapolis, Minnesota 55455, United States
  • Columbia Presbyterian Medical Center
    New York, New York 10032, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Midstate Cardiology
    Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00097968
Lead sponsor
Novartis Pharmaceuticals
First posted
Dec 2, 2004
Start date
Aug 2004
Primary completion
Apr 2005
Last update
Jul 12, 2010

Study contacts

Richard Dorent, MD
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vascular Diseases→

Other studies from this sponsor

Novartis Pharmaceuticals

Start the discussion