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

March 2, 2006
March 29, 2010
April 2004
June 2009   (final data collection date for primary outcome measure)
International Society for Heart and Lung Transplantation Mean Biopsy Score (6, 12 month average) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
International Society for Heart and Lung Transplantation Mean Biopsy Score (6 month average)
Complete list of historical versions of study NCT00299221 on ClinicalTrials.gov Archive Site
  • 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 ]
  • mortality
  • Incidence of cytomegalovirus
  • Incidence of Allograft vasculopathy
  • 1 year mean biopsy score
  • risk of new onset diabetes mellitus
  • time to wean corticosteroids
Not Provided
Not Provided
 
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Transplantation
  • Drug: Tacrolimus
    tacrolimus
    Other Name: Prograf
  • Drug: mycophenolate mofetil therapy
    MMF
    Other Name: CellCept
  • Active Comparator: MONOTHERAPY
    Tacrolimus alone
    Intervention: Drug: Tacrolimus
  • Active Comparator: Combination therapy
    tacrolimus with mycophenolate mofetil
    Interventions:
    • Drug: Tacrolimus
    • Drug: mycophenolate mofetil therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00299221
TICTAC
No
David Baran, Director, Heart Failure / Transplant Research, Newark Beth Israel Medical Center
Newark Beth Israel Medical Center
Astellas Pharma Inc
Principal Investigator: David A Baran, MD Newark Beth Israel Medical Center
Newark Beth Israel Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP