Trial Outcomes & Findings for Belatacept 3 Month Post Transplant Conversion Study (NCT NCT02213068)
NCT ID: NCT02213068
Last Updated: 2023-02-08
Results Overview
To assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
2 years
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Belatacept + MPA
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
9
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Belatacept 3 Month Post Transplant Conversion Study
Baseline characteristics by cohort
| Measure |
Belatacept + MPA
n=9 Participants
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 Participants
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 Participants
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 16.21 • n=5 Participants
|
49.75 years
STANDARD_DEVIATION 13.33 • n=7 Participants
|
49.70 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
48.81 years
STANDARD_DEVIATION 13.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Incidence of Delayed Graft Function
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Incidence of Diabetes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Incidence of Hypertension
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Positive Cross-Match
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Kidney Function as eGFR
|
67.33 mL/min/1.73m2
STANDARD_DEVIATION 17.89 • n=5 Participants
|
67.75 mL/min/1.73m2
STANDARD_DEVIATION 20.01 • n=7 Participants
|
70.70 mL/min/1.73m2
STANDARD_DEVIATION 20.70 • n=5 Participants
|
70.19 mL/min/1.73m2
STANDARD_DEVIATION 20.19 • n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
Outcome measures
| Measure |
Belatacept + MPA
n=9 Participants
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 Participants
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 Participants
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion)
|
-5.44 mL/min/1.73m2
Standard Error 5.43
|
8.08 mL/min/1.73m2
Standard Error 5.74
|
-0.38 mL/min/1.73m2
Standard Error 3.94
|
PRIMARY outcome
Timeframe: 2 yearsNumber of Participants with Acute Rejection (AR). AR is defined as allograft dysfunctions in the setting of recipient immune system engaging an allo-response against the kidney transplant.
Outcome measures
| Measure |
Belatacept + MPA
n=9 Participants
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 Participants
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 Participants
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Acute Rejection
|
4 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of Subjects with a functioning Graft
Outcome measures
| Measure |
Belatacept + MPA
n=9 Participants
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 Participants
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 Participants
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Graft Survival
|
8 Participants
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of Subjects alive at the end of 24 months
Outcome measures
| Measure |
Belatacept + MPA
n=9 Participants
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 Participants
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 Participants
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Patient Survival
|
9 Participants
|
7 Participants
|
9 Participants
|
Adverse Events
Belatacept + MPA
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Belatacept + Low-Dose Tac
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Tacrolimus + MPA Standard Treatment Regimen
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Belatacept + MPA
n=9 participants at risk
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 participants at risk
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 participants at risk
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Infections and infestations
Death
|
0.00%
0/9 • 2 years
|
0.00%
0/8 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Endocrine disorders
Death
|
0.00%
0/9 • 2 years
|
12.5%
1/8 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/9 • 2 years
|
12.5%
1/8 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
Other adverse events
| Measure |
Belatacept + MPA
n=9 participants at risk
subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
Belatacept + Low-Dose Tac
n=8 participants at risk
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
|
Tacrolimus + MPA Standard Treatment Regimen
n=10 participants at risk
Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
|
|---|---|---|---|
|
Infections and infestations
CMV
|
11.1%
1/9 • Number of events 1 • 2 years
|
12.5%
1/8 • Number of events 1 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Infections and infestations
BK infections
|
33.3%
3/9 • Number of events 3 • 2 years
|
50.0%
4/8 • Number of events 4 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
3/9 • Number of events 3 • 2 years
|
37.5%
3/8 • Number of events 3 • 2 years
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/8 • 2 years
|
30.0%
3/10 • Number of events 3 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place