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Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation

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ClinicalTrials.gov Identifier: NCT00331162
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : June 5, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Graft Rejection
Interventions Drug: Alemtuzumab
Drug: Anti-Thymocyte Globulin
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description 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: 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

Period Title: Overall Study
Started 113 109
Completed 113 109
Not Completed 0 0
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 113 109 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 109 participants 222 participants
51  (12) 49  (13) 50  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 109 participants 222 participants
Female
46
  40.7%
47
  43.1%
93
  41.9%
Male
67
  59.3%
62
  56.9%
129
  58.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 109 participants 222 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
34
  30.1%
36
  33.0%
70
  31.5%
White
74
  65.5%
69
  63.3%
143
  64.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   4.4%
4
   3.7%
9
   4.1%
1.Primary Outcome
Title Patient Survival
Hide Description The number of patients that survived after transplantation occurred was reported.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 113 109
Measure Type: Count of Participants
Unit of Measure: Participants
109
  96.5%
104
  95.4%
2.Primary Outcome
Title Graft Survival
Hide Description The number of patients with graft survival after kidney alone, simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK) transplant.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number the analyzed in one or more rows differs from overall number analyzed because there were subgroups for transplantation.
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 113 109
Measure Type: Count of Participants
Unit of Measure: Participants
Kidney alone Number Analyzed 85 participants 95 participants
78
  91.8%
84
  88.4%
SPK Number Analyzed 24 participants 14 participants
21
  87.5%
13
  92.9%
PAK Number Analyzed 4 participants 0 participants
4
 100.0%
0
3.Primary Outcome
Title Acute Rejection
Hide Description The number of patients with acute rejection after transplantation was reported.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 113 109
Measure Type: Count of Participants
Unit of Measure: Participants
16
  14.2%
28
  25.7%
4.Secondary Outcome
Title Hematologic Adverse Events
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Infectious Adverse Events
Hide Description Number of events for infectious adverse events were reported (Polyoma virus nephropathy (PVD), cytomegalovirus (CMV), bacterial and fungal infections).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 113 109
Measure Type: Number
Unit of Measure: number of events
CMV 9 18
PVN 1 8
Fungal infections 11 11
Bacterial Infections 89 92
6.Secondary Outcome
Title Other Adverse Events
Hide Description Number of patients with other adverse events (posttransplant lymphoproliferative disorder (PTLD), and nonskin malignancy), were reported.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 113 109
Measure Type: Count of Participants
Unit of Measure: Participants
PTLD
0
   0.0%
1
   0.9%
Other Nonskin Malignancy
0
   0.0%
2
   1.8%
7.Secondary Outcome
Title Cost
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Health Status and Quality of Life
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected.
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alemtuzumab Anti-Thymocyte Globulin
Hide Arm/Group Description 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: 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

All-Cause Mortality
Alemtuzumab Anti-Thymocyte Globulin
Affected / at Risk (%) Affected / at Risk (%)
Total   4/113 (3.54%)   5/109 (4.59%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab Anti-Thymocyte Globulin
Affected / at Risk (%) Affected / at Risk (%)
Total   11/113 (9.73%)   44/109 (40.37%) 
Blood and lymphatic system disorders     
Pulmonary Embolism *  0/113 (0.00%)  1/109 (0.92%) 
Posttransplant lymphoproliferative disorder *  0/113 (0.00%)  1/109 (0.92%) 
Other (nonskin) Malignancy *  0/113 (0.00%)  2/109 (1.83%) 
Cardiac disorders     
Cardiovascular Disease *  2/113 (1.77%)  2/109 (1.83%) 
Infections and infestations     
Fungal Infection *  11/113 (9.73%)  11/109 (10.09%) 
Viral Infections *  10/113 (8.85%)  27/109 (24.77%) 
Renal and urinary disorders     
Renal Allograft Pseudoaneurysm *  1/113 (0.88%)  0/109 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alemtuzumab Anti-Thymocyte Globulin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/113 (0.00%)   0/109 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Alan Farney
Organization: Wake Forest University Health Sciences
Phone: 336-716-6510
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00331162     History of Changes
Other Study ID Numbers: BG04-498
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: April 3, 2018
Results First Posted: June 5, 2018
Last Update Posted: September 6, 2018