Trial Outcomes & Findings for Improved Induction and Maintenance Immunosuppression in Kidney Transplantation (NCT NCT00556933)
NCT ID: NCT00556933
Last Updated: 2023-09-18
Results Overview
Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (\<5%; none or minimal), 1 (\>5% - \<25%; mild), 2 (\>25% - \<50%, moderate), or 3 (\>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher's exact test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
Two years
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
|
Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
|
|---|---|---|---|---|
|
Single vs. Divided-dose rATG Induction
STARTED
|
45
|
45
|
45
|
45
|
|
Single vs. Divided-dose rATG Induction
COMPLETED
|
43
|
37
|
39
|
43
|
|
Single vs. Divided-dose rATG Induction
NOT COMPLETED
|
2
|
8
|
6
|
2
|
|
CNI Withdrawal vs. Minimization
STARTED
|
43
|
37
|
39
|
43
|
|
CNI Withdrawal vs. Minimization
COMPLETED
|
42
|
33
|
36
|
41
|
|
CNI Withdrawal vs. Minimization
NOT COMPLETED
|
1
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
|
Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
|
|---|---|---|---|---|
|
Single vs. Divided-dose rATG Induction
Protocol Violation
|
2
|
3
|
3
|
0
|
|
Single vs. Divided-dose rATG Induction
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Single vs. Divided-dose rATG Induction
Pancreas transplantation
|
0
|
2
|
2
|
2
|
|
Single vs. Divided-dose rATG Induction
Death
|
0
|
1
|
0
|
0
|
|
Single vs. Divided-dose rATG Induction
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Single vs. Divided-dose rATG Induction
Kidney graft primary non-function
|
0
|
1
|
0
|
0
|
|
CNI Withdrawal vs. Minimization
Pancreas transplantation
|
1
|
1
|
0
|
0
|
|
CNI Withdrawal vs. Minimization
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
CNI Withdrawal vs. Minimization
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
CNI Withdrawal vs. Minimization
Graft loss
|
0
|
1
|
2
|
0
|
|
CNI Withdrawal vs. Minimization
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Improved Induction and Maintenance Immunosuppression in Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=44 Participants
Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over \<24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=44 Participants
Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=45 Participants
Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti
n=45 Participants
Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection..
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 12 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
47.2 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian/Asian
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
39 participants
n=5 Participants
|
41 participants
n=4 Participants
|
157 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non Caucasian/Asian
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Patient Body Mass Index (BMI)
|
28.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 6.6 • n=7 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 6.9 • n=4 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.7 • n=21 Participants
|
|
Donor type
Deceased donor
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Donor type
Living donor
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
28 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Deceased-donor Cold Ischemia Time
|
14.3 Hours
STANDARD_DEVIATION 7 • n=5 Participants
|
13.7 Hours
STANDARD_DEVIATION 4.1 • n=7 Participants
|
14.7 Hours
STANDARD_DEVIATION 5.7 • n=5 Participants
|
15.4 Hours
STANDARD_DEVIATION 11 • n=4 Participants
|
14.5 Hours
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Patient Panel Reactive Antibody (PRA)(%)
|
0.6 % reactive
STANDARD_DEVIATION 2.3 • n=5 Participants
|
1.0 % reactive
STANDARD_DEVIATION 4.8 • n=7 Participants
|
1.1 % reactive
STANDARD_DEVIATION 6.3 • n=5 Participants
|
1.3 % reactive
STANDARD_DEVIATION 7.8 • n=4 Participants
|
1.0 % reactive
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Donor/recipient height ratio
|
0.98 ratio
STANDARD_DEVIATION 0.07 • n=5 Participants
|
1.00 ratio
STANDARD_DEVIATION 0.17 • n=7 Participants
|
0.98 ratio
STANDARD_DEVIATION 0.16 • n=5 Participants
|
1.00 ratio
STANDARD_DEVIATION 0.16 • n=4 Participants
|
0.99 ratio
STANDARD_DEVIATION 0.1 • n=21 Participants
|
|
Donor age
|
40.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
37.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
|
Donor gender
Male
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
17 participants
n=5 Participants
|
20 participants
n=4 Participants
|
78 participants
n=21 Participants
|
|
Donor gender
Female
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
28 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
|
Donor BMI
|
27.7 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.0 • n=7 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 5.1 • n=4 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.8 • n=21 Participants
|
|
Donor final serum creatinine
|
1.0 mg/dl
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.1 mg/dl
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.0 mg/dl
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.0 mg/dl
STANDARD_DEVIATION 0.5 • n=4 Participants
|
1.0 mg/dl
STANDARD_DEVIATION 0.5 • n=21 Participants
|
|
Adult Cadaver Donor Nyberg Grade
|
10.5 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 7.0 • n=7 Participants
|
11.8 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
15.4 units on a scale
STANDARD_DEVIATION 7.8 • n=4 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 7.4 • n=21 Participants
|
|
Pediatric vs. Adult Donor
Pediatric donor
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Pediatric vs. Adult Donor
Adult donor
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
42 participants
n=5 Participants
|
42 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Donor/Recipient High-Risk CMV Serostatus
CMV High-risk
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
25 participants
n=5 Participants
|
33 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Donor/Recipient High-Risk CMV Serostatus
CMV Low-risk
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
12 participants
n=4 Participants
|
70 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Two yearsProtocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (\<5%; none or minimal), 1 (\>5% - \<25%; mild), 2 (\>25% - \<50%, moderate), or 3 (\>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher's exact test.
Outcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=36 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=29 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=28 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=29 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).
Banff histopathology cumulative grade = 0
|
43 percentage of participants
|
40 percentage of participants
|
53 percentage of participants
|
51 percentage of participants
|
|
Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).
Banff histopathology cumulative grade = 2
|
16 percentage of participants
|
9 percentage of participants
|
2 percentage of participants
|
7 percentage of participants
|
|
Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).
Banff histopathology cumulative grade = 1
|
37 percentage of participants
|
46 percentage of participants
|
45 percentage of participants
|
41 percentage of participants
|
|
Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).
Banff histopathology cumulative grade = 3
|
4 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
PRIMARY outcome
Timeframe: Two yearsCalculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.
Outcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=38 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=42 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=44 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Average of Renal Function
Average GFR, months 1-3
|
50.4 ml/min/1.73m2
Standard Deviation 16.0
|
50.1 ml/min/1.73m2
Standard Deviation 12.5
|
53.6 ml/min/1.73m2
Standard Deviation 14.4
|
50.4 ml/min/1.73m2
Standard Deviation 17.0
|
|
Average of Renal Function
Average GFR, months 4-6
|
57.3 ml/min/1.73m2
Standard Deviation 17.6
|
57.3 ml/min/1.73m2
Standard Deviation 12.5
|
60.2 ml/min/1.73m2
Standard Deviation 15.6
|
54.8 ml/min/1.73m2
Standard Deviation 13.2
|
|
Average of Renal Function
Average GFR, months 7-9
|
54.8 ml/min/1.73m2
Standard Deviation 16.5
|
55.0 ml/min/1.73m2
Standard Deviation 11.8
|
61.0 ml/min/1.73m2
Standard Deviation 15.8
|
55.8 ml/min/1.73m2
Standard Deviation 13.2
|
|
Average of Renal Function
Average GFR, months 10-12
|
55.8 ml/min/1.73m2
Standard Deviation 16.6
|
55.6 ml/min/1.73m2
Standard Deviation 12.1
|
57.4 ml/min/1.73m2
Standard Deviation 16.7
|
56.6 ml/min/1.73m2
Standard Deviation 14.4
|
|
Average of Renal Function
Average GFR, months 13-15
|
56.8 ml/min/1.73m2
Standard Deviation 19.2
|
57.3 ml/min/1.73m2
Standard Deviation 14.3
|
61.8 ml/min/1.73m2
Standard Deviation 15.4
|
58.5 ml/min/1.73m2
Standard Deviation 16.6
|
|
Average of Renal Function
Average GFR, months 16-18
|
57.6 ml/min/1.73m2
Standard Deviation 20.9
|
56.3 ml/min/1.73m2
Standard Deviation 14.8
|
62.3 ml/min/1.73m2
Standard Deviation 17.6
|
56.6 ml/min/1.73m2
Standard Deviation 18.4
|
|
Average of Renal Function
Average GFR, months 19-21
|
56.6 ml/min/1.73m2
Standard Deviation 20.0
|
54.8 ml/min/1.73m2
Standard Deviation 17.3
|
60.2 ml/min/1.73m2
Standard Deviation 14.7
|
56.8 ml/min/1.73m2
Standard Deviation 18.9
|
|
Average of Renal Function
Average GFR, months 22-24
|
56.9 ml/min/1.73m2
Standard Deviation 21.9
|
57.0 ml/min/1.73m2
Standard Deviation 16.2
|
62.9 ml/min/1.73m2
Standard Deviation 18.6
|
57.6 ml/min/1.73m2
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Two yearsNumber of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.
Outcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=215 Number of possible events
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=215 Number of possible events
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=215 Number of possible events
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=220 Number of possible events
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Safety Profile
|
11 Events
|
14 Events
|
10 Events
|
17 Events
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=42 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=41 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=45 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)
|
7 participants
|
5 participants
|
6 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=42 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=41 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=45 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)
|
7 participants
|
4 participants
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Seven daysOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=41 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=44 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.
|
3 participants
|
1 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Two yearsGraft failure = permanent return of patient to dialysis.
Outcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=41 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=44 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Graft Survival
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=44 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=44 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=45 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=45 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Patient Survival
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=25 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=26 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=24 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=30 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Lymphoid Cell Sub-type CD3 Absolute Numbers
|
446 CD3 Cell Numbers/mm^3
Standard Deviation 403
|
375 CD3 Cell Numbers/mm^3
Standard Deviation 564
|
392 CD3 Cell Numbers/mm^3
Standard Deviation 319
|
266 CD3 Cell Numbers/mm^3
Standard Deviation 211
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=43 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=43 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=44 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Six monthsOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=26 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=26 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=22 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=24 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)
|
10 participants
|
7 participants
|
5 participants
|
12 participants
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus
n=25 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus
n=23 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=23 Participants
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.
|
Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
n=29 Participants
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
|
|---|---|---|---|---|
|
Ratio of CD4/CD8 Lymphoid Cells
|
0.84 Ratio of cell counts
Standard Deviation 0.55
|
0.84 Ratio of cell counts
Standard Deviation 0.41
|
0.98 Ratio of cell counts
Standard Deviation 0.53
|
1.01 Ratio of cell counts
Standard Deviation 0.57
|
Adverse Events
Group 1
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2
Serious events: 15 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 3
Serious events: 18 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 4
Serious events: 21 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=44 participants at risk
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Group 2
n=44 participants at risk
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Group 3
n=45 participants at risk
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i
|
Group 4
n=45 participants at risk
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve
|
|---|---|---|---|---|
|
Infections and infestations
Wound Abscess
|
0.00%
0/44 • Up to two years.
|
0.00%
0/44 • Up to two years.
|
6.7%
3/45 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
|
Surgical and medical procedures
Wound Dehiscence
|
2.3%
1/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
|
Renal and urinary disorders
Acute Tubular Necrosis
|
6.8%
3/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
13.3%
6/45 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
|
Injury, poisoning and procedural complications
Rabbit Anti-Thymocyte Globulin (rATG) Reaction
|
2.3%
1/44 • Up to two years.
|
4.5%
2/44 • Up to two years.
|
8.9%
4/45 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
|
Renal and urinary disorders
Renal Allograft Primary Non-function
|
0.00%
0/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
|
Renal and urinary disorders
Renal Allograft Failure
|
0.00%
0/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
|
Renal and urinary disorders
Ureteral Stricture
|
4.5%
2/44 • Up to two years.
|
6.8%
3/44 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
|
Surgical and medical procedures
Lymphocele Requiring Drainage
|
6.8%
3/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
8.9%
4/45 • Up to two years.
|
|
Surgical and medical procedures
Repair of Wound Hernia at Transplantation Incision
|
4.5%
2/44 • Up to two years.
|
9.1%
4/44 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
20.0%
9/45 • Up to two years.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/44 • Up to two years.
|
0.00%
0/44 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/44 • Up to two years.
|
4.5%
2/44 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
|
Immune system disorders
Serum Sickness
|
0.00%
0/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
4.4%
2/45 • Up to two years.
|
|
General disorders
Death
|
0.00%
0/44 • Up to two years.
|
2.3%
1/44 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
2.2%
1/45 • Up to two years.
|
Other adverse events
| Measure |
Group 1
n=44 participants at risk
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Group 2
n=44 participants at risk
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
|
Group 3
n=45 participants at risk
Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i
|
Group 4
n=45 participants at risk
Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
New-onset Hyperlipidemia after Transplantation
|
25.0%
11/44 • Up to two years.
|
22.7%
10/44 • Up to two years.
|
15.6%
7/45 • Up to two years.
|
17.8%
8/45 • Up to two years.
|
|
Blood and lymphatic system disorders
Incomplete Rabbit Anti-Thymocyte Globulin Induction
|
2.3%
1/44 • Up to two years.
|
4.5%
2/44 • Up to two years.
|
8.9%
4/45 • Up to two years.
|
0.00%
0/45 • Up to two years.
|
Additional Information
R. Brian Stevens, MD, PhD
Wright State University, Dayton, Ohio
Phone: 937-545-4817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place