Trial Outcomes & Findings for Tocilizumab for Renal Graft Inflammation (NCT NCT02108600)
NCT ID: NCT02108600
Last Updated: 2021-03-09
Results Overview
Proportion of participants in each group who had a 1 point decrease in inflammation based on Banff scoring on renal allograft biopsy at 6 months compared to baseline. The Banff ti- score can be 0, 1, 2 or 3.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Standard of Care
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Tocilizumab for Renal Graft Inflammation
Baseline characteristics by cohort
| Measure |
Standard of Care
n=14 Participants
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 Participants
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive reg
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=5 Participants
|
53.5 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsProportion of participants in each group who had a 1 point decrease in inflammation based on Banff scoring on renal allograft biopsy at 6 months compared to baseline. The Banff ti- score can be 0, 1, 2 or 3.
Outcome measures
| Measure |
Standard of Care
n=14 Participants
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 Participants
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Change in Inflammation on Renal Allograft Biopsy From Baseline to 6 Months
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The urine samples were not adequate for analysis and therefore this outcome was not analyzed.
Change in urinary cytokines from baseline at 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 6 monthsProportion of participants who developed de novo DSA from baseline to 6 months
Outcome measures
| Measure |
Standard of Care
n=14 Participants
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 Participants
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Development of Donor Specific Anti-HLA Antibodies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: In the interval between baseline and 6 MonthsProportion of patients with acute rejection in each group
Outcome measures
| Measure |
Standard of Care
n=14 Participants
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 Participants
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Incidence of Acute Rejection
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tocilizumab (TCZ) Group
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=14 participants at risk
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 participants at risk
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Infections and infestations
sepsis
|
0.00%
0/14 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
6.2%
1/16 • Number of events 1 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
|
Infections and infestations
pyelonephritis
|
0.00%
0/14 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
6.2%
1/16 • Number of events 1 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
|
Renal and urinary disorders
subcapsular hematoma
|
0.00%
0/14 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
6.2%
1/16 • Number of events 1 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
Other adverse events
| Measure |
Standard of Care
n=14 participants at risk
Will continue usual immunosuppression and not receive any specific intervention.
|
Tocilizumab (TCZ) Group
n=16 participants at risk
Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
|
|---|---|---|
|
Infections and infestations
pneumonia
|
0.00%
0/14 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
6.2%
1/16 • Number of events 1 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
|
Infections and infestations
skin infection
|
0.00%
0/14 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
6.2%
1/16 • Number of events 1 • 1 year
used Common Terminology Criteria for Adverse Events (CTCAE) grades
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place