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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
David A. Baran, MD, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00299221
First received: March 2, 2006
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: September 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Immunosuppression
Interventions: Drug: Tacrolimus
Drug: combination therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pts recruited from April 2004-Aug 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consent often obtained after transplant

Reporting Groups
  Description
Monotherapy These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
Combination Therapy These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.

Participant Flow:   Overall Study
    Monotherapy     Combination Therapy  
STARTED     79     71  
COMPLETED     79     71  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Monotherapy These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
Combination Therapy These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
Total Total of all reporting groups

Baseline Measures
    Monotherapy     Combination Therapy     Total  
Number of Participants  
[units: participants]
  79     71     150  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     64     57     121  
>=65 years     15     14     29  
Age  
[units: years]
Mean (Standard Deviation)
  54.7  (10.7)     54.6  (11.6)     54.65  (10)  
Gender  
[units: participants]
     
Female     17     11     28  
Male     62     60     122  
Region of Enrollment  
[units: participants]
     
United States     79     71     150  



  Outcome Measures
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1.  Primary:   Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation   [ Time Frame: 6 months ]

2.  Secondary:   Percent of Patients Alive at One Year Post-transplant   [ Time Frame: 1 year ]

3.  Secondary:   Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant   [ Time Frame: 1 year ]

4.  Secondary:   Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant   [ Time Frame: 1 year ]

5.  Secondary:   Mean ISHLT Biopsy Score Over First Year Post-transplant   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial enrolled 150 patients, but cannot be used to generalize care to other patients without careful consideration of risks and benefits. All patients had corticosteorids weaned so this trial doesn't assess the risk of steroid weaning.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Baran MD
Organization: Newark Beth Israel Medical Center
phone: 973-926-7205
e-mail: dbaran@barnabashealth.org


Publications of Results:

Responsible Party: David A. Baran, MD, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00299221     History of Changes
Other Study ID Numbers: TICTAC
Study First Received: March 2, 2006
Results First Received: September 10, 2010
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board