Trial Outcomes & Findings for Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols (NCT NCT01172418)
NCT ID: NCT01172418
Last Updated: 2023-09-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
at one year post-transplant
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Thymoglobulin and Daclizumab
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols
Baseline characteristics by cohort
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 participants
STANDARD_DEVIATION 12 • n=99 Participants
|
49.4 participants
STANDARD_DEVIATION 13 • n=107 Participants
|
49.65 participants
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
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
|
91 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=99 Participants
|
100 participants
n=107 Participants
|
200 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at one year post-transplantOutcome measures
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Incidence of Acute Rejection at One Year Post-transplant
|
14 percentage of patients having BPAR
|
13 percentage of patients having BPAR
|
SECONDARY outcome
Timeframe: at 1 year post-transplantOutcome measures
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Graft Survival
|
92.9 actuarial percentage of participants
Interval 87.9 to 98.0
|
92.0 actuarial percentage of participants
Interval 86.7 to 97.3
|
SECONDARY outcome
Timeframe: at 3 years post-transplantOutcome measures
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Graft Survival
|
90.9 actuarial percentage of participants
Interval 85.2 to 96.5
|
86.9 actuarial percentage of participants
Interval 80.2 to 93.5
|
SECONDARY outcome
Timeframe: at 1 year post-transplantOutcome measures
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Patient Survival
|
96.9 actuarial percentage of participants
Interval 93.5 to 100.4
|
97 actuarial percentage of participants
Interval 93.6 to 100.4
|
SECONDARY outcome
Timeframe: at 3 years post-transplantOutcome measures
| Measure |
Thymoglobulin and Daclizumab
n=100 Participants
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=100 Participants
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Patient Survival
|
95.9 actuarial percentage of participants
Interval 91.9 to 99.8
|
91.8 actuarial percentage of participants
Interval 86.4 to 97.3
|
Adverse Events
Thymoglobulin and Daclizumab
Serious events: 29 serious events
Other events: 8 other events
Deaths: 0 deaths
Thymoglobulin and Alemtuzumab
Serious events: 25 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thymoglobulin and Daclizumab
n=75 participants at risk；n=100 participants at risk
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=70 participants at risk；n=100 participants at risk
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Infections and infestations
Patients who developed an infection that required hospitalization
|
29.0%
29/100
Total Numbers at Risk for Serious Adverse Events (100+100=200) and Other Adverse Events (75+70=145) were inconsistent, because in order to determine how many study participants developed NODAT (new onset diabetes after transplant), study participants having pre-transplant diabetes (25 in Groups I, and 30 in Group II) were excluded.
|
25.0%
25/100
Total Numbers at Risk for Serious Adverse Events (100+100=200) and Other Adverse Events (75+70=145) were inconsistent, because in order to determine how many study participants developed NODAT (new onset diabetes after transplant), study participants having pre-transplant diabetes (25 in Groups I, and 30 in Group II) were excluded.
|
Other adverse events
| Measure |
Thymoglobulin and Daclizumab
n=75 participants at risk；n=100 participants at risk
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction
|
Thymoglobulin and Alemtuzumab
n=70 participants at risk；n=100 participants at risk
Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction.
|
|---|---|---|
|
Endocrine disorders
occurrence of NODAT in patients without pretransplant diabetes
|
10.7%
8/75 • Number of events 8
Total Numbers at Risk for Serious Adverse Events (100+100=200) and Other Adverse Events (75+70=145) were inconsistent, because in order to determine how many study participants developed NODAT (new onset diabetes after transplant), study participants having pre-transplant diabetes (25 in Groups I, and 30 in Group II) were excluded.
|
11.4%
8/70 • Number of events 8
Total Numbers at Risk for Serious Adverse Events (100+100=200) and Other Adverse Events (75+70=145) were inconsistent, because in order to determine how many study participants developed NODAT (new onset diabetes after transplant), study participants having pre-transplant diabetes (25 in Groups I, and 30 in Group II) were excluded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place