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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would 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 was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included 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 was compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Active Comparator | Tacrolimus alone |
|
| Combination therapy | Active Comparator | tacrolimus with mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | tacrolimus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation | Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Alive at One Year Post-transplant | Percent of patients alive at one year post-transplant. In other words, all cause mortality over time | 1 year |
| Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Baran, MD | Newark Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States | ||
| Mt. Sinai Cardiovascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17919618 | Result | Baran DA, Zucker MJ, Arroyo LH, Alwarshetty MM, Ramirez MR, Prendergast TW, Goldstein DJ, Camacho M, Gass AL, Carr C, Cohen M. Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial). J Heart Lung Transplant. 2007 Oct;26(10):992-7. doi: 10.1016/j.healun.2007.07.022. | |
| 21216835 |
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Consent often obtained after transplant
Pts recruited from April 2004-Aug 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Combination Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation | Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6. | all pts, intention to treat | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
1 year
Cytomegalovirus (CMV) disease
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment | mortality, tabulated as secondary outcome measure |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Baran MD | Newark Beth Israel Medical Center | 973-926-7205 | dbaran@barnabashealth.org |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| D003327 | Coronary Disease |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D003131 | Combined Modality Therapy |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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| combination therapy | Drug | MMF |
|
|
Number of patients developing cytomegalovirus disease by 1 year post-transplant
| 1 year |
| Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant | Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant | 1 year |
| Mean ISHLT Biopsy Score Over First Year Post-transplant | Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6. | 1 year |
| New York |
| New York |
| 10029 |
| United States |
| Baran DA, Zucker MJ, Arroyo LH, Camacho M, Goldschmidt ME, Nicholls SJ, Prevost-Fernandez J, Carr C, Adams L, Pardi S, Hou V, Binetti M, McCahill J, Chichetti J, Viloria V, Sanagustin MG, Ebuenga-Smith J, Mele L, Martin A, Blicharz D, Wolski K, Olesnicky L, Qian F, Gass AL, Cohen M. A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial. Circ Heart Fail. 2011 Mar;4(2):129-37. doi: 10.1161/CIRCHEARTFAILURE.110.958520. Epub 2011 Jan 7. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
| Secondary | Percent of Patients Alive at One Year Post-transplant | Percent of patients alive at one year post-transplant. In other words, all cause mortality over time | all pts, intention to treat | Posted | Number | percent of participants | 1 year |
|
|
|
| Secondary | Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant | Number of patients developing cytomegalovirus disease by 1 year post-transplant | all patients | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant | Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant | Percent of patients with allograft CAD at one year post-transplant | Posted | Number | patients | 1 year |
|
|
|
| Secondary | Mean ISHLT Biopsy Score Over First Year Post-transplant | Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6. | all pts, Intention to treat | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
|
|
| 2 |
| 79 |
| 0 |
| 79 |
| EG001 | 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. | 1 | 71 | 0 | 71 |
|
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| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D002208 |
| Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |