Trial Outcomes & Findings for C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI (NCT NCT02134314)
NCT ID: NCT02134314
Last Updated: 2018-06-25
Results Overview
Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
First 7 days post-transplant
Results posted on
2018-06-25
Participant Flow
Participant milestones
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
Baseline characteristics by cohort
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.66 years
STANDARD_DEVIATION 7.74 • n=93 Participants
|
58.14 years
STANDARD_DEVIATION 11.18 • n=4 Participants
|
57.9 years
STANDARD_DEVIATION 9.54 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African-American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not African-American
|
31 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Diabetes
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Donor Age
|
49.17 years
STANDARD_DEVIATION 12.35 • n=93 Participants
|
45.57 years
STANDARD_DEVIATION 15.69 • n=4 Participants
|
47.37 years
STANDARD_DEVIATION 14.13 • n=27 Participants
|
|
Donor Creatinine
|
1.78 mg/dL
STANDARD_DEVIATION 1.44 • n=93 Participants
|
1.75 mg/dL
STANDARD_DEVIATION 1.92 • n=4 Participants
|
1.77 mg/dL
STANDARD_DEVIATION 1.69 • n=27 Participants
|
|
Donor DCD Cause of Death
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Donor KDPI
|
67.71 %
STANDARD_DEVIATION 21.83 • n=93 Participants
|
64.63 %
STANDARD_DEVIATION 25.39 • n=4 Participants
|
66.17 %
STANDARD_DEVIATION 23.56 • n=27 Participants
|
|
Donor KDPI equal to or greater than 85%
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Transplant Cold Ischemia Time
|
18.27 hours
STANDARD_DEVIATION 4.89 • n=93 Participants
|
19.84 hours
STANDARD_DEVIATION 6.10 • n=4 Participants
|
19.06 hours
STANDARD_DEVIATION 5.54 • n=27 Participants
|
|
Anti-HLA DSA
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
HLA Class I Antibodies Present
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
HLA Class II Antibodies Present
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Treatment with Thymoglobulin at transplantation
|
25 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Treatment with Alemtuzumab at transplantation
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: First 7 days post-transplantNumber of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=34 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.
|
29 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: First 7 days post-transplantThe proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=34 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.
|
15 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: First 7 days post-transplantNumber of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.
|
30 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: First 7 days post-transplantMean quantity of dialysis sessions per patient in the first 7 days post transplant.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=34 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.
|
0.97 dialysis sessions
Standard Deviation 1.22
|
1.54 dialysis sessions
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Up to 90 days post-transplantMean serum creatinine on day 90 in mg/dL
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Serum Creatinine
|
1.3 mg/dL
Standard Deviation 0.317
|
1.7 mg/dL
Standard Deviation 1.410
|
SECONDARY outcome
Timeframe: Up to 90 days post-transplantCreatinine clearance calculated based on serum creatinine, milliliters per minute.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=34 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Creatinine Clearance
|
56.4 ml/minute
Standard Deviation 15.558
|
51.2 ml/minute
Standard Deviation 17.335
|
SECONDARY outcome
Timeframe: 24 hours post-transplant24 hour urine output post-transplantation measured in milliliters
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
24h Urine Output
|
873.5 milliliters
Standard Deviation 1257.0
|
607.8 milliliters
Standard Deviation 782.4
|
SECONDARY outcome
Timeframe: 15 to 30 days post-transplantationMean number of patients on dialysis at 15 to 30 days post-transplant
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Mean Number of Patients on Dialysis
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: First 7 days post-transplantDGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \>70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \>70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \<70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \<70% with need for dialysis.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=34 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)
|
15 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 9 months post-transplantOverall incidence of serious adverse events in the C1INH and placebo groups, number of events.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Overall Incidence of Serious Adverse Events
|
11 events
|
16 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 days post-transplantPatient survival at 90 days post-transplantation
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Patient Survival
|
35 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 days post-transplantNumber of acute cellular and antibody mediated rejection episodes by day 90.
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Rate of Acute Cellular Rejection (ACR)
|
0 episodes
|
0 episodes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90 Post-transplantNumber of Participants with Graft Survival at 90 Days Post-Transplant
Outcome measures
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 Participants
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 Participants
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Graft Survival
|
34 Participants
|
34 Participants
|
Adverse Events
C1-Inhibitor (Berinert) (Human) (C1INH)
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
Normal Saline
Serious events: 10 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 participants at risk
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 participants at risk
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Infections and infestations
Neutropenia/Fever
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Infections and infestations
Viral infection
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Infections and infestations
Purulent Drainage from wound
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Infections and infestations
Acute Encephalopathy
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Infections and infestations
Sepsis from Urinary Tract Infection
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Flash pulmonary edema
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
A fib, shortness of breath, chest pain
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Right leg DVT
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Upper extermity/facial swelling, SVC syndrome
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
A flutter
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Afib/ventricular tachycardia
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Non ST segment elevation
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Renal and urinary disorders
Elevated creatinine/edema
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Renal and urinary disorders
Nephrectomy due to poor perfusion
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Renal and urinary disorders
Urine Leak
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Renal and urinary disorders
Peri-renal transplant hematoma
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Nervous system disorders
Slurred speech/weakness/fatigue
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
Other adverse events
| Measure |
C1-Inhibitor (Berinert) (Human) (C1INH)
n=35 participants at risk
35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
Normal Saline
n=35 participants at risk
35 patients will receive placebo in addition to standard of care immunosuppressive therapy.
Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses
|
|---|---|---|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
14.3%
5/35 • Number of events 5 • Adverse event data collected up to 9 months post transplant.
|
|
Endocrine disorders
Hyperglycemia
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • Number of events 3 • Adverse event data collected up to 9 months post transplant.
|
8.6%
3/35 • Number of events 3 • Adverse event data collected up to 9 months post transplant.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
7/35 • Number of events 7 • Adverse event data collected up to 9 months post transplant.
|
20.0%
7/35 • Number of events 7 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Hypertension
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
20.0%
7/35 • Number of events 7 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Number of events 3 • Adverse event data collected up to 9 months post transplant.
|
20.0%
7/35 • Number of events 7 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Edema
|
20.0%
7/35 • Number of events 7 • Adverse event data collected up to 9 months post transplant.
|
11.4%
4/35 • Number of events 4 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
8.6%
3/35 • Number of events 3 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Shortness of Breath
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
8.6%
3/35 • Number of events 3 • Adverse event data collected up to 9 months post transplant.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
|
Cardiac disorders
Chest Pain
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
2.9%
1/35 • Number of events 1 • Adverse event data collected up to 9 months post transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.7%
2/35 • Number of events 2 • Adverse event data collected up to 9 months post transplant.
|
0.00%
0/35 • Adverse event data collected up to 9 months post transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place