Trial Outcomes & Findings for Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation (NCT NCT00331162)
NCT ID: NCT00331162
Last Updated: 2018-09-06
Results Overview
The number of patients that survived after transplantation occurred was reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
222 participants
Primary outcome timeframe
5 years
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
Alemtuzumab
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
109
|
|
Overall Study
COMPLETED
|
113
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
Baseline characteristics by cohort
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49 years
STANDARD_DEVIATION 13 • n=7 Participants
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThe number of patients that survived after transplantation occurred was reported.
Outcome measures
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Patient Survival
|
109 Participants
|
104 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Number the analyzed in one or more rows differs from overall number analyzed because there were subgroups for transplantation.
The number of patients with graft survival after kidney alone, simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK) transplant.
Outcome measures
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Graft Survival
Kidney alone
|
78 Participants
|
84 Participants
|
|
Graft Survival
SPK
|
21 Participants
|
13 Participants
|
|
Graft Survival
PAK
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThe number of patients with acute rejection after transplantation was reported.
Outcome measures
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Acute Rejection
|
16 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No data was collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsNumber of events for infectious adverse events were reported (Polyoma virus nephropathy (PVD), cytomegalovirus (CMV), bacterial and fungal infections).
Outcome measures
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Infectious Adverse Events
CMV
|
9 number of events
|
18 number of events
|
|
Infectious Adverse Events
PVN
|
1 number of events
|
8 number of events
|
|
Infectious Adverse Events
Fungal infections
|
11 number of events
|
11 number of events
|
|
Infectious Adverse Events
Bacterial Infections
|
89 number of events
|
92 number of events
|
SECONDARY outcome
Timeframe: 2 yearsNumber of patients with other adverse events (posttransplant lymphoproliferative disorder (PTLD), and nonskin malignancy), were reported.
Outcome measures
| Measure |
Alemtuzumab
n=113 Participants
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 Participants
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Other Adverse Events
Other Nonskin Malignancy
|
0 Participants
|
2 Participants
|
|
Other Adverse Events
PTLD
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No data was collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: No data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Alemtuzumab
Serious events: 11 serious events
Other events: 0 other events
Deaths: 4 deaths
Anti-Thymocyte Globulin
Serious events: 44 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Alemtuzumab
n=113 participants at risk
Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
|
Anti-Thymocyte Globulin
n=109 participants at risk
Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.
Give first dose over 6 hours, subsequent doses over 4 hours.
Premedication to be given with the first 3 doses:
Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours
|
|---|---|---|
|
Cardiac disorders
Cardiovascular Disease
|
1.8%
2/113 • 5 years
|
1.8%
2/109 • 5 years
|
|
Renal and urinary disorders
Renal Allograft Pseudoaneurysm
|
0.88%
1/113 • 5 years
|
0.00%
0/109 • 5 years
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
0.00%
0/113 • 5 years
|
0.92%
1/109 • 5 years
|
|
Blood and lymphatic system disorders
Posttransplant lymphoproliferative disorder
|
0.00%
0/113 • 5 years
|
0.92%
1/109 • 5 years
|
|
Infections and infestations
Fungal Infection
|
9.7%
11/113 • 5 years
|
10.1%
11/109 • 5 years
|
|
Infections and infestations
Viral Infections
|
8.8%
10/113 • 5 years
|
24.8%
27/109 • 5 years
|
|
Blood and lymphatic system disorders
Other (nonskin) Malignancy
|
0.00%
0/113 • 5 years
|
1.8%
2/109 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place