Trial Outcomes & Findings for A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based (NCT NCT01820572)
NCT ID: NCT01820572
Last Updated: 2021-01-05
Results Overview
Percentage of participants who survive with a functional graft at 24 months post-randomization
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
446 participants
Primary outcome timeframe
at 24 Months
Results posted on
2021-01-05
Participant Flow
446 Enrolled and Treated
Participant milestones
| Measure |
Belatacept
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Randomization
STARTED
|
223
|
223
|
|
Randomization
COMPLETED
|
221
|
222
|
|
Randomization
NOT COMPLETED
|
2
|
1
|
|
Treatment Period
STARTED
|
221
|
222
|
|
Treatment Period
COMPLETED
|
195
|
186
|
|
Treatment Period
NOT COMPLETED
|
26
|
36
|
Reasons for withdrawal
| Measure |
Belatacept
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Randomization
Not Treated
|
2
|
1
|
|
Treatment Period
Adverse Event
|
12
|
7
|
|
Treatment Period
Death
|
3
|
3
|
|
Treatment Period
Lack of Efficacy
|
1
|
0
|
|
Treatment Period
poor/non compliance
|
0
|
3
|
|
Treatment Period
request to discontinue
|
6
|
11
|
|
Treatment Period
No longer meets study criteria
|
3
|
10
|
|
Treatment Period
withdrew consent
|
1
|
2
|
Baseline Characteristics
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Baseline characteristics by cohort
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
54.0 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
132 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
191 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 MonthsPopulation: All Randomized Participants
Percentage of participants who survive with a functional graft at 24 months post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Percentage of Participants Who Survive With a Functional Graft at 24 Months
|
98.2 Percentage
Interval 95.5 to 99.5
|
97.3 Percentage
Interval 95.2 to 99.4
|
SECONDARY outcome
Timeframe: at 12 MonthsPopulation: All Randomized Participants
Percentage of participants who survive with a functional graft at 12 months post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Percentage of Participants Who Survive With a Functional Graft at 12 Months
|
98.7 Percentage
Interval 96.1 to 99.7
|
99.1 Percentage
Interval 96.8 to 99.9
|
SECONDARY outcome
Timeframe: at 12 and 24 MonthsPopulation: All Randomized Participants
The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization includes participants with at least one cellular and/or humoral BPAR event.
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
at 12 Months
|
18 Participants
|
4 Participants
|
|
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
at 24 Months
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: at 12 and 24 monthsPopulation: All Randomized Participants who had a BPAR
Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
Outcome measures
| Measure |
Belatacept
n=20 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=6 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Participants With Varying Severity of BPAR
at 12 Months · Mild Acute (IA)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 12 Months · Mild Acute (IB)1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 12 Months · Moderate Acute (IIA)
|
7 Participants
|
0 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 12 Months · Moderate Acute (IIB)
|
6 Participants
|
0 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 12 Months · Severe Acute (III)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 24 Months · Mild Acute (IA)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 24 Months · Mild Acute (IB)1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 24 Months · Moderate Acute (IIA)
|
7 Participants
|
1 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 24 Months · Moderate Acute (IIB)
|
6 Participants
|
0 Participants
|
|
Number of Participants With Varying Severity of BPAR
at 24 Months · Severe Acute (III)
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at 12 and 24 monthsPopulation: All Randomized Participants
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
at 12 Months
|
13.2 Percent Change
Interval 10.4 to 16.0
|
-0.3 Percent Change
Interval -2.9 to 2.4
|
|
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
at 24 Months
|
15.2 Percent Change
Interval 11.9 to 18.6
|
0.3 Percent Change
Interval -2.9 to 3.4
|
SECONDARY outcome
Timeframe: at 12 and 24 monthsPopulation: All Randomized Participants
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
at 12 Months
|
5.6 mL/min/1.73m²
Interval 4.3 to 6.9
|
-0.7 mL/min/1.73m²
Interval -2.0 to 0.6
|
|
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
at 24 Months
|
6.2 mL/min/1.73m²
Interval 4.7 to 7.7
|
-1.0 mL/min/1.73m²
Interval -2.6 to 0.5
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: All Randomized Participants
Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Screening
|
49.8 mL/min/1.73m²
Interval 48.2 to 51.5
|
49.7 mL/min/1.73m²
Interval 48.2 to 51.2
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Baseline
|
49.6 mL/min/1.73m²
Interval 48.0 to 51.2
|
50.7 mL/min/1.73m²
Interval 49.2 to 52.2
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 3
|
53.0 mL/min/1.73m²
Interval 51.1 to 54.9
|
50.2 mL/min/1.73m²
Interval 48.3 to 52.0
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 6
|
53.3 mL/min/1.73m²
Interval 51.3 to 55.3
|
50.9 mL/min/1.73m²
Interval 49.1 to 52.7
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 9
|
53.7 mL/min/1.73m²
Interval 51.8 to 55.6
|
50.7 mL/min/1.73m²
Interval 48.9 to 52.5
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 12
|
55.5 mL/min/1.73m²
Interval 53.4 to 57.6
|
50.5 mL/min/1.73m²
Interval 48.7 to 52.4
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 18
|
56.5 mL/min/1.73m²
Interval 54.5 to 58.5
|
51.3 mL/min/1.73m²
Interval 49.2 to 53.4
|
|
Mean Calculated Glomerular Filtration Rate (cGFR)
Month 24
|
55.7 mL/min/1.73m²
Interval 53.7 to 57.7
|
51.1 mL/min/1.73m²
Interval 49.0 to 53.2
|
SECONDARY outcome
Timeframe: at 12 and 24 MonthsPopulation: All Randomized Participants
Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Slope Analysis of cGFR
Baseline to 12 Months
|
0.241 mL/min/1.73m²/month
Interval 0.103 to 0.378
|
0.004 mL/min/1.73m²/month
Interval -0.137 to 0.145
|
|
Slope Analysis of cGFR
Month 3 to Month 12
|
0.281 mL/min/1.73m²/month
Interval 0.072 to 0.49
|
-0.159 mL/min/1.73m²/month
Interval -0.372 to 0.055
|
|
Slope Analysis of cGFR
Baseline to Month 24
|
0.685 mL/min/1.73m²/month
Interval 0.426 to 0.945
|
-0.112 mL/min/1.73m²/month
Interval -0.379 to 0.155
|
|
Slope Analysis of cGFR
Month 3 to Month 24
|
0.658 mL/min/1.73m²/month
Interval 0.332 to 0.984
|
-0.277 mL/min/1.73m²/month
Interval -0.614 to 0.06
|
SECONDARY outcome
Timeframe: at 12 and 24 MonthsPopulation: All Randomized Participants
Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Slope Analysis of 1/Serum Creatinine
Baseline to 12 Months
|
0.034 mg/dL/month
Interval 0.016 to 0.051
|
-0.003 mg/dL/month
Interval -0.02 to 0.015
|
|
Slope Analysis of 1/Serum Creatinine
Month 3 to Month 12
|
0.033 mg/dL/month
Interval 0.007 to 0.059
|
-0.021 mg/dL/month
Interval -0.048 to 0.006
|
|
Slope Analysis of 1/Serum Creatinine
Baseline to Month 24
|
0.00868 mg/dL/month
Interval 0.00537 to 0.01199
|
-0.00203 mg/dL/month
Interval -0.00544 to 0.00138
|
|
Slope Analysis of 1/Serum Creatinine
Month 3 to Month 24
|
0.00814 mg/dL/month
Interval 0.00412 to 0.01217
|
-0.00425 mg/dL/month
Interval -0.00842 to -0.00009
|
SECONDARY outcome
Timeframe: at 12 and 24 MonthsPopulation: All Randomized Participants
Percentage of participants with \> 5% and \>10% improvement over baseline cGFR, at 12 and 24 months post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
>5% improvement at 12 months
|
53.4 Percentage
|
28.7 Percentage
|
|
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
>10% improvement at 12 months
|
43.9 Percentage
|
21.5 Percentage
|
|
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
>5% improvement at 24 months
|
54.3 Percentage
|
29.6 Percentage
|
|
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
>10% improvement at 24 months
|
48.4 Percentage
|
22.0 Percentage
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: All Randomized Participants
Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Urine Protein/ Creatinine Ratio (UPCR)
at Baseline
|
17.80 mg/mmol
Interval 16.03 to 19.58
|
18.61 mg/mmol
Interval 15.08 to 22.14
|
|
Mean Urine Protein/ Creatinine Ratio (UPCR)
at 3 months
|
22.87 mg/mmol
Interval 19.88 to 25.86
|
20.61 mg/mmol
Interval 15.5 to 25.73
|
|
Mean Urine Protein/ Creatinine Ratio (UPCR)
at 6 months
|
23.42 mg/mmol
Interval 19.71 to 27.12
|
20.85 mg/mmol
Interval 15.36 to 26.35
|
|
Mean Urine Protein/ Creatinine Ratio (UPCR)
at 12 months
|
29.11 mg/mmol
Interval 21.86 to 36.35
|
21.67 mg/mmol
Interval 17.7 to 25.65
|
|
Mean Urine Protein/ Creatinine Ratio (UPCR)
at 24 months
|
28.81 mg/mmol
Interval 23.71 to 33.91
|
24.56 mg/mmol
Interval 19.01 to 30.1
|
SECONDARY outcome
Timeframe: at 12 and 24 monthsPopulation: All Randomized Participants
Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Diastolic BP at 12 Months
|
-1.5 mmHg
Interval -2.9 to 0.0
|
-0.6 mmHg
Interval -2.1 to 1.0
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Diastolic BP at 24 Months
|
-1.7 mmHg
Interval -3.3 to 0.0
|
0.5 mmHg
Interval -1.3 to 2.3
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic BP at 12 Months
|
-1.6 mmHg
Interval -4.0 to 0.9
|
0.1 mmHg
Interval -2.5 to 2.8
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic BP at 24 Months
|
-1.3 mmHg
Interval -4.1 to 1.6
|
1.2 mmHg
Interval -1.7 to 4.1
|
SECONDARY outcome
Timeframe: at baseline, 12 and 24 MonthsPopulation: All Randomized Participants
The total number of antihypertensive medications used to control hypertension
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Antihypertensive Medications Used to Control Hypertension
at Baseline
|
2.1 Number of medications
Interval 1.0 to 5.0
|
2.2 Number of medications
Interval 1.0 to 6.0
|
|
Number of Antihypertensive Medications Used to Control Hypertension
at 12 Months
|
2.3 Number of medications
Interval 1.0 to 7.0
|
2.2 Number of medications
Interval 1.0 to 6.0
|
|
Number of Antihypertensive Medications Used to Control Hypertension
at 24 Months
|
2.3 Number of medications
Interval 1.0 to 8.0
|
2.3 Number of medications
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: at baseline, 12 and 24 monthsPopulation: All Randomized Participants
Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Participants With Donor Specific Antibodies (DSA)
Pre Existing at baseline
|
10 Participants
|
26 Participants
|
|
Number of Participants With Donor Specific Antibodies (DSA)
De Novo at 12 Months
|
2 Participants
|
9 Participants
|
|
Number of Participants With Donor Specific Antibodies (DSA)
De Novo at 24 Months
|
2 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 12 MonthsPopulation: All randomized and Treated Participants
The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization. Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.
Outcome measures
| Measure |
Belatacept
n=223 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=223 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Number of Symptom Occurrence and Symptom Distress
Baseline symptom occurrence
|
87.8 Scores on a scale
Standard Deviation 20.06
|
90.7 Scores on a scale
Standard Deviation 21.04
|
|
Mean Number of Symptom Occurrence and Symptom Distress
Baseline symptom distress
|
28.7 Scores on a scale
Standard Deviation 27.07
|
34.8 Scores on a scale
Standard Deviation 28.30
|
|
Mean Number of Symptom Occurrence and Symptom Distress
week 6 symptom occurrence
|
79.0 Scores on a scale
Standard Deviation 16.52
|
88.6 Scores on a scale
Standard Deviation 21.36
|
|
Mean Number of Symptom Occurrence and Symptom Distress
week 6 symptom distress
|
19.8 Scores on a scale
Standard Deviation 21.41
|
32.4 Scores on a scale
Standard Deviation 29.55
|
|
Mean Number of Symptom Occurrence and Symptom Distress
Month 3 symptom occurrence
|
80.5 Scores on a scale
Standard Deviation 16.74
|
89.9 Scores on a scale
Standard Deviation 23.45
|
|
Mean Number of Symptom Occurrence and Symptom Distress
Month 3 symptom distress
|
21.4 Scores on a scale
Standard Deviation 23.08
|
35.2 Scores on a scale
Standard Deviation 32.04
|
|
Mean Number of Symptom Occurrence and Symptom Distress
month 6 symptom occurrence
|
80.5 Scores on a scale
Standard Deviation 17.50
|
91.8 Scores on a scale
Standard Deviation 23.72
|
|
Mean Number of Symptom Occurrence and Symptom Distress
month 6 symptom distress
|
22.4 Scores on a scale
Standard Deviation 22.18
|
36.3 Scores on a scale
Standard Deviation 31.39
|
|
Mean Number of Symptom Occurrence and Symptom Distress
month 12 symptom occurrence
|
82.3 Scores on a scale
Standard Deviation 20.08
|
91.0 Scores on a scale
Standard Deviation 22.33
|
|
Mean Number of Symptom Occurrence and Symptom Distress
month 12 symptom distress
|
25.8 Scores on a scale
Standard Deviation 25.32
|
34.4 Scores on a scale
Standard Deviation 30.82
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: As Treated Population
Number of participants with an adverse event of special interests. Adverse events of special interest include: Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.
Outcome measures
| Measure |
Belatacept
n=221 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=222 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Participants With an Adverse Event of Special Interest
Serious Infections
|
37 participants
|
44 participants
|
|
Number of Participants With an Adverse Event of Special Interest
PTLD
|
1 participants
|
0 participants
|
|
Number of Participants With an Adverse Event of Special Interest
PML
|
0 participants
|
0 participants
|
|
Number of Participants With an Adverse Event of Special Interest
Malignancies
|
17 participants
|
12 participants
|
|
Number of Participants With an Adverse Event of Special Interest
Tuberculosis infections
|
0 participants
|
0 participants
|
|
Number of Participants With an Adverse Event of Special Interest
CNS Infections
|
0 participants
|
0 participants
|
|
Number of Participants With an Adverse Event of Special Interest
Viral Infections
|
5 participants
|
9 participants
|
|
Number of Participants With an Adverse Event of Special Interest
Infusion Related Reactions
|
13 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: All Randomized and Treated Participants
Number of participants with Marked Laboratory Abnormalities
Outcome measures
| Measure |
Belatacept
n=221 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=222 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Sodium (Abnormal high)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin (Abnormal Low)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin (Abnormal high)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Platelet count (Abnormal low)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Leukocytes (Abnormal low)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Lymphocytes (Abnormal low)
|
29 Participants
|
10 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Lymphocytes (Abnormal high)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils Absolute (Abnormal low)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Alanine Aminotransferase (Abnormal High)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Alkaline Phosphatase (Abnormal High)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Aspartate Aminotransferase (Abnormal High)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total Bilirubin (Abnormal High)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Creatine (Abnormal High)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Protein/Creatinine Ratio (Abnormal High)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Bicarbonate (Abnormal High)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total Calcium (Abnormal low)
|
0 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total Calcium (Abnormal high)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Magnesium (Abnormal low)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Magnesium (Abnormal high)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Phosphorus (Abnormal Low)
|
14 Participants
|
12 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Potassium (Abnormal low)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Potassium (Abnormal high)
|
1 Participants
|
5 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Sodium (Abnormal low)
|
4 Participants
|
9 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Albumin (Abnormal low)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total Cholesterol (Abnormal High)
|
13 Participants
|
17 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Serum Glucose (Abnormal low)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Serum Glucose (Abnormal high)
|
18 Participants
|
18 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Triglycerides (Abnormal high)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Uric Acid (Abnormal high)
|
15 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: at 12 and 24 monthsPopulation: All Randomized and Treated Participants
The mean change from baseline in measured heart rate
Outcome measures
| Measure |
Belatacept
n=221 Participants
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=222 Participants
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Mean Change From Baseline in Vital Signs: Heart Rate
Change from baseline at 12 months
|
-1.8 beats per minute (bpm)
Interval -3.3 to -0.2
|
-0.6 beats per minute (bpm)
Interval -2.2 to 1.0
|
|
Mean Change From Baseline in Vital Signs: Heart Rate
Change from baseline at 24 months
|
-1.9 beats per minute (bpm)
Interval -3.5 to -0.3
|
1.0 beats per minute (bpm)
Interval -0.8 to 2.8
|
Adverse Events
Belatacept
Serious events: 107 serious events
Other events: 174 other events
Deaths: 4 deaths
CNI-Based Regimen
Serious events: 95 serious events
Other events: 168 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Belatacept
n=221 participants at risk
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=222 participants at risk
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.90%
2/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Angina unstable
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.90%
2/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.45%
1/221 • 116 Weeks
|
1.4%
3/222 • 116 Weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.90%
2/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.90%
2/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Cardiac disorders
Sinus bradycardia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
1.4%
3/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Eye disorders
Angle closure glaucoma
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
1/221 • 116 Weeks
|
2.7%
6/222 • 116 Weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
General disorders
Chest pain
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
General disorders
Chronic fatigue syndrome
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
General disorders
Impaired healing
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
General disorders
Pneumatosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
General disorders
Pyrexia
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
General disorders
Sudden cardiac death
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
General disorders
Sudden death
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Immune system disorders
Chronic allograft nephropathy
|
0.45%
1/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Immune system disorders
Kidney transplant rejection
|
8.6%
19/221 • 116 Weeks
|
3.2%
7/222 • 116 Weeks
|
|
Immune system disorders
Renal transplant failure
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Anal abscess
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
BK virus infection
|
0.45%
1/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Infections and infestations
Bacterial pyelonephritis
|
1.4%
3/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Bronchitis
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Cellulitis
|
0.45%
1/221 • 116 Weeks
|
1.4%
3/222 • 116 Weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Infections and infestations
Diverticulitis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Erysipelas
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Escherichia bacteraemia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Escherichia infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Gangrene
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.45%
1/221 • 116 Weeks
|
2.7%
6/222 • 116 Weeks
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Hepatic cyst infection
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Herpes zoster
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Infected cyst
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Infected lymphocele
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Influenza
|
0.90%
2/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Infections and infestations
Localised infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Lung infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Osteomyelitis
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Pneumonia
|
2.3%
5/221 • 116 Weeks
|
3.2%
7/222 • 116 Weeks
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Post procedural infection
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Pulmonary sepsis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Pyelonephritis
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Infections and infestations
Renal graft infection
|
0.90%
2/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Sepsis
|
1.8%
4/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Infections and infestations
Systemic candida
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Infections and infestations
Urinary tract infection
|
3.2%
7/221 • 116 Weeks
|
3.2%
7/222 • 116 Weeks
|
|
Infections and infestations
Urosepsis
|
2.7%
6/221 • 116 Weeks
|
1.4%
3/222 • 116 Weeks
|
|
Infections and infestations
Wound infection
|
0.45%
1/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.45%
1/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Shunt blood flow excessive
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Investigations
Blood creatinine increased
|
0.90%
2/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Investigations
Donor specific antibody present
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Investigations
Norovirus test positive
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.45%
1/221 • 116 Weeks
|
1.4%
3/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.90%
2/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.0%
11/221 • 116 Weeks
|
2.3%
5/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.4%
3/221 • 116 Weeks
|
2.3%
5/222 • 116 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.8%
4/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Hemiparesis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/221 • 116 Weeks
|
1.4%
3/222 • 116 Weeks
|
|
Psychiatric disorders
Confusional state
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Psychiatric disorders
Depressive delusion
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
4/221 • 116 Weeks
|
2.3%
5/222 • 116 Weeks
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Haematuria
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Renal disorder
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.45%
1/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.45%
1/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.90%
2/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
|
Vascular disorders
Extremity necrosis
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Haematoma
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Hypertension
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Hypotension
|
0.90%
2/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/221 • 116 Weeks
|
0.90%
2/222 • 116 Weeks
|
|
Vascular disorders
Peripheral artery stenosis
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.45%
1/221 • 116 Weeks
|
0.00%
0/222 • 116 Weeks
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/221 • 116 Weeks
|
0.45%
1/222 • 116 Weeks
|
Other adverse events
| Measure |
Belatacept
n=221 participants at risk
Participants who converted to belatacept treatment from CNI-Based
|
CNI-Based Regimen
n=222 participants at risk
Participants who continued on CNI-Based regimens
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
12/221 • 116 Weeks
|
5.9%
13/222 • 116 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
21.3%
47/221 • 116 Weeks
|
27.5%
61/222 • 116 Weeks
|
|
Gastrointestinal disorders
Nausea
|
6.8%
15/221 • 116 Weeks
|
5.0%
11/222 • 116 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
10/221 • 116 Weeks
|
5.9%
13/222 • 116 Weeks
|
|
General disorders
Fatigue
|
10.0%
22/221 • 116 Weeks
|
6.8%
15/222 • 116 Weeks
|
|
General disorders
Oedema peripheral
|
10.0%
22/221 • 116 Weeks
|
15.8%
35/222 • 116 Weeks
|
|
General disorders
Pyrexia
|
9.0%
20/221 • 116 Weeks
|
7.7%
17/222 • 116 Weeks
|
|
Infections and infestations
Bronchitis
|
10.4%
23/221 • 116 Weeks
|
8.1%
18/222 • 116 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
19.9%
44/221 • 116 Weeks
|
22.5%
50/222 • 116 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
17/221 • 116 Weeks
|
8.1%
18/222 • 116 Weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
37/221 • 116 Weeks
|
14.9%
33/222 • 116 Weeks
|
|
Investigations
Blood creatinine increased
|
9.0%
20/221 • 116 Weeks
|
8.1%
18/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
21/221 • 116 Weeks
|
10.4%
23/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
18/221 • 116 Weeks
|
9.9%
22/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
5/221 • 116 Weeks
|
5.4%
12/222 • 116 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
11/221 • 116 Weeks
|
9.0%
20/222 • 116 Weeks
|
|
Nervous system disorders
Dizziness
|
6.8%
15/221 • 116 Weeks
|
3.6%
8/222 • 116 Weeks
|
|
Nervous system disorders
Headache
|
12.2%
27/221 • 116 Weeks
|
10.4%
23/222 • 116 Weeks
|
|
Nervous system disorders
Tremor
|
2.7%
6/221 • 116 Weeks
|
5.4%
12/222 • 116 Weeks
|
|
Psychiatric disorders
Insomnia
|
4.1%
9/221 • 116 Weeks
|
5.4%
12/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
31/221 • 116 Weeks
|
9.0%
20/222 • 116 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
10/221 • 116 Weeks
|
5.4%
12/222 • 116 Weeks
|
|
Vascular disorders
Hypertension
|
13.1%
29/221 • 116 Weeks
|
9.5%
21/222 • 116 Weeks
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60