Trial Outcomes & Findings for C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection (NCT NCT02936479)
NCT ID: NCT02936479
Last Updated: 2019-07-11
Results Overview
number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
24 months
Results posted on
2019-07-11
Participant Flow
Participant milestones
| Measure |
Berinert Treatment
C1-Inhibitor (INH) (Berinert): C1 esterase inhibitor, Berinert, 25-50 units/kg, intravenous, 7 doses on days 1, 3, 5, 7, 9, 11, 13 and 50 units/kg twice weekly for a total study period of 6 months.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Baseline characteristics by cohort
| Measure |
Berinert Treatment
n=1 Participants
C1-INH (Berinert)
|
|---|---|
|
Age, Customized
54 Years Old
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsnumber of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration
Outcome measures
| Measure |
Berinert Treatment
n=1 Participants
C1-INH (Berinert)
|
|---|---|
|
Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
|
1 Participants
|
Adverse Events
Berinert Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Berinert Treatment
n=1 participants at risk
C1-INH (Berinert)
|
|---|---|
|
Skin and subcutaneous tissue disorders
skin infection
|
100.0%
1/1 • Number of events 1 • 17 months
|
|
Renal and urinary disorders
urinary tract infection
|
100.0%
1/1 • Number of events 1 • 17 months
|
Additional Information
Cecilia Deterville, MS, CCRC
NYU Langone Health- Transplant Institute
Phone: 212.263.3620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place