Clinical trial NCT00300274: Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Official title: A 24-month, Multi-center, Randomized, Open-label, Non-inferiority Study of Efficacy and Safety Comparing Two Exposures of Concentration-controlled Everolimus With Reduced Cyclosporine Versus 3.0 g Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft Rejection
Keywords: Everolimus
heart transplant
heart disease
transplantation
heart IVUS assessment at 12 months
rate of graft loss
acute rejection episodes
survival
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-08
Enrollment: 721
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
* The graft must be functional at time of randomization.

Exclusion Criteria:

* Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants.
* Patients who are recipients of ABO incompatible transplants.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Composite Efficacy Failure at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months
timeFrame: 12 Months
measure: Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months
timeFrame: 12 Months
measure: Change From Baseline in the Average Maximum Intimal Thickness at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12
timeFrame: 12 Months
measure: Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
timeFrame: 12 Months
measure: Percentage of Participants With Composite Efficacy Failure at 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months
timeFrame: 24 Months
measure: Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
timeFrame: 24 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stanford
country: United States
facility: Stanford U Sch, Falk Cardiovasular Research Ctr.
state: California
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola Univerisity Medical School
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Recanati Miller Transplant Institute
state: New York
city: Chapel Hill
country: United States
facility: UNC Division of Cardiology
state: North Carolina
city: Durham
country: United States
facility: Duke University Heart Failure Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiovascular Consultants
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch, Div of Cardio Thoracic
state: Texas
city: Houston
country: United States
facility: Methodist Hospital/DeBakey Heart Failure Research Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Madison
country: United States
facility: University of Wisconsin - Madison Medical School
state: Wisconsin
city: Milwakee
country: United States
facility: St. Luke's Medical Center Cardiac Services
state: Wisconsin
city: Rosario
country: Argentina
facility: Sanatorio Parque
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Fundacion Favalaro
city: Darlinghurst
country: Australia
facility: St Vincents Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Vienna
country: Austria
facility: Universitaet Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: New Halifax Infirmary
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Sainte-Foy
country: Canada
facility: Institut Univ. de cardiologie et pneumologie de Quebec
state: Quebec
city: Lyon
country: France
facility: Hopital Cardiologique de Lyon
city: Paris
country: France
facility: Hopital Georges Pompidou
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Strasbourg
country: France
facility: CHU de Strasbourg Hopital Civil Medicale B
city: Vandoeuvre les Nancy
country: France
facility: CHU Hopital de Brabois
city: Bad Oeynhausen
country: Germany
facility: Herz- u. Diabeteszentrum NRW/Ruhr-Univ. Bochum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Kliniken der Med. Hochschule
city: Kiel
country: Germany
facility: Universitaetsklinikum Kiel
city: Regensburg
country: Germany
facility: Universitaetsklinik Regensburg
city: Bologna
country: Italy
facility: Az. Osp. di Bologna Policl. S. Orsola-Malpighi Univ. degli Studi
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu
city: Padova
country: Italy
facility: A.O.-Universita di Padova-Universita degli Studi
city: Pavio
country: Italy
facility: Fodazione IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Camillo-Forlanini
city: Torino
country: Italy
facility: Az. Ospedaliero-Universitaria S. Giovanni Battista di Torino
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Oslo
country: Norway
facility: Rikshospitalet, Hjertemedisinskavdeling
city: San Juan
country: Puerto Rico
facility: Cardiovascular Center of Puerto Rico and the Caribbean
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: