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Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (TICTAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Newark Beth Israel Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00299221
First received: March 2, 2006
Last updated: March 29, 2010
Last verified: February 2009
History of Changes
  Purpose

This is a study to compare less intense immunosuppression with a more traditional approach. The hypothesis is that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.


Condition Intervention Phase
Heart Transplantation
 Drug: Tacrolimus
Drug: mycophenolate mofetil therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newark Beth Israel Medical Center:

Primary Outcome Measures:
  • International Society for Heart and Lung Transplantation Mean Biopsy Score (6, 12 month average) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of cytomegalovirus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of Allograft vasculopathy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 1 year mean biopsy score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • risk of new onset diabetes mellitus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • time to wean corticosteroids [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MONOTHERAPY
Tacrolimus alone
 Drug: Tacrolimus
tacrolimus
Other Name: Prograf
Active Comparator: Combination therapy
tacrolimus with mycophenolate mofetil
 Drug: Tacrolimus
tacrolimus
Other Name: Prograf
Drug: mycophenolate mofetil therapy
MMF
Other Name: CellCept

Detailed Description:

This is a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis is that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning will provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean.

The primary endpoint is the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints include the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound will be compared between groups.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (at least 18 years old)
  • Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
  • Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients

Exclusion Criteria:

  • Age less than 18
  • Inability to provide proper informed consent
  • Combined organ transplantation
  • Re-Transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299221

Locations
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Mt. Sinai Cardiovascular Institute
New York, New York, United States, 10029
Sponsors and Collaborators
Newark Beth Israel Medical Center
Astellas Pharma Inc
Investigators
Principal Investigator: David A Baran, MD Newark Beth Israel Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Baran, Director, Heart Failure / Transplant Research, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00299221     History of Changes
Other Study ID Numbers: TICTAC
Study First Received: March 2, 2006
Last Updated: March 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Newark Beth Israel Medical Center:
immunosuppression
steroid withdrawal
rejection
coronary disease
cytomegalovirus infection

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013