Trial Outcomes & Findings for Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (NCT NCT00299221)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

6 months

Results posted on

2015-05-28

Participant Flow

Pts recruited from April 2004-Aug 2008

Consent often obtained after transplant

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	79	71
Overall Study COMPLETED	79	71
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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 n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=99 Participants	57 Participants n=107 Participants	121 Participants n=206 Participants
Age, Categorical >=65 years	15 Participants n=99 Participants	14 Participants n=107 Participants	29 Participants n=206 Participants
Age, Continuous	54.7 years STANDARD_DEVIATION 10.7 • n=99 Participants	54.6 years STANDARD_DEVIATION 11.6 • n=107 Participants	54.65 years STANDARD_DEVIATION 10 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	11 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Male	62 Participants n=99 Participants	60 Participants n=107 Participants	122 Participants n=206 Participants
Region of Enrollment United States	79 participants n=99 Participants	71 participants n=107 Participants	150 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: all pts, intention to treat

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.

Outcome measures

Outcome measures
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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.
Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation	0.7 units on a scale Standard Deviation 0.44	0.65 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 1 year

Population: all pts, intention to treat

Percent of patients alive at one year post-transplant. In other words, all cause mortality over time

Outcome measures

Outcome measures
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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.
Percent of Patients Alive at One Year Post-transplant	98 percent of participants	98 percent of participants

SECONDARY outcome

Timeframe: 1 year

Population: all patients

Number of patients developing cytomegalovirus disease by 1 year post-transplant

Outcome measures

Outcome measures
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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.
Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant	2 participants	2 participants

SECONDARY outcome

Timeframe: 1 year

Population: Percent of patients with allograft CAD at one year post-transplant

Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant

Outcome measures

Outcome measures
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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.
Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant	0 patients	0 patients

SECONDARY outcome

Timeframe: 1 year

Population: all pts, Intention to treat

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.

Outcome measures

Outcome measures
Measure	Monotherapy n=79 Participants 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 n=71 Participants 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.
Mean ISHLT Biopsy Score Over First Year Post-transplant	0.67 units on a scale Standard Deviation 0.39	0.62 units on a scale Standard Deviation 0.39

Adverse Events

Monotherapy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Monotherapy n=79 participants at risk 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 n=71 participants at risk 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.
General disorders death	2.5% 2/79 • Number of events 2 • 1 year Cytomegalovirus (CMV) disease	1.4% 1/71 • Number of events 1 • 1 year Cytomegalovirus (CMV) disease

Other adverse events

Adverse event data not reported

Additional Information

David Baran MD

Newark Beth Israel Medical Center

Phone: 973-926-7205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place