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C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI (C1INHDGF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134314
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Stanley Jordan, MD, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions End Stage Renal Disease
Kidney Failure
Delayed Graft Function
Ischemic Reperfusion Injury
Interventions Drug: C1 Esterase Inhibitor
Drug: Placebo
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 35 35
Completed 34 34
Not Completed 1 1
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
57.66  (7.74) 58.14  (11.18) 57.9  (9.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
15
  42.9%
13
  37.1%
28
  40.0%
Male
20
  57.1%
22
  62.9%
42
  60.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
African-American
4
  11.4%
4
  11.4%
8
  11.4%
Not African-American
31
  88.6%
31
  88.6%
62
  88.6%
[1]
Measure Description: Patients were categorized as either African American or not African American.
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
21
  60.0%
20
  57.1%
41
  58.6%
Donor Age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
49.17  (12.35) 45.57  (15.69) 47.37  (14.13)
Donor Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
1.78  (1.44) 1.75  (1.92) 1.77  (1.69)
Donor DCD Cause of Death   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
11
  31.4%
12
  34.3%
23
  32.9%
[1]
Measure Description: The kidney transplant donor was a Donor after Cardiac Death (DCD).
Donor KDPI   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 35 participants 35 participants 70 participants
67.71  (21.83) 64.63  (25.39) 66.17  (23.56)
[1]
Measure Description: Mean kidney transplant donor Kidney Donor Profile Index (KDPI), shown as a percentage. Kidneys with a high KDPI are associated with higher rates of DGF and worse long term survival in comparison to those with a low KDPI. In this study, the eligibility criteria included recipients of kidney allografts from ECD (or KDPI >/= 85) donors. A KDPI >/= 85 confers the highest risk for DGF and allograft loss.
Donor KDPI equal to or greater than 85%   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
10
  28.6%
11
  31.4%
21
  30.0%
[1]
Measure Description: The donor's Kidney Donor Profile Index (KDPI) was equal to or greater than 85%. Mean kidney transplant donor Kidney Donor Profile Index (KDPI), shown as a percentage. Kidneys with a high KDPI are associated with higher rates of DGF and worse long term survival in comparison to those with a low KDPI. In this study, the eligibility criteria included recipients of kidney allografts from ECD (or KDPI >/= 85) donors. A KDPI >/= 85 confers the highest risk for DGF and allograft loss.
Transplant Cold Ischemia Time  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 35 participants 35 participants 70 participants
18.27  (4.89) 19.84  (6.10) 19.06  (5.54)
Anti-HLA DSA   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
3
   8.6%
2
   5.7%
5
   7.1%
[1]
Measure Description: Anti-Human leukocyte antigen (HLA) Donor Specific Antibody (DSA)
HLA Class I Antibodies Present   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
2
   5.7%
1
   2.9%
3
   4.3%
[1]
Measure Description: Human leukocyte antigen (HLA) Class I Antibodies
HLA Class II Antibodies Present   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
1
   2.9%
1
   2.9%
2
   2.9%
[1]
Measure Description: Human leukocyte antigen (HLA) Class II Antibodies
Treatment with Thymoglobulin at transplantation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
25
  71.4%
28
  80.0%
53
  75.7%
[1]
Measure Description: Patients who received thymoglobulin as an induction agent at transplant
Treatment with Alemtuzumab at transplantation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
10
  28.6%
7
  20.0%
17
  24.3%
[1]
Measure Description: Patients who received alemtuzumab (Campath) as an induction agent at transplant
1.Primary Outcome
Title Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.
Hide Description Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5
Time Frame First 7 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 34 35
Measure Type: Count of Participants
Unit of Measure: Participants
29
  85.3%
32
  91.4%
2.Primary Outcome
Title Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.
Hide Description The 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).
Time Frame First 7 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 34 35
Measure Type: Count of Participants
Unit of Measure: Participants
15
  44.1%
21
  60.0%
3.Primary Outcome
Title Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.
Hide Description Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant.
Time Frame First 7 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
30
  85.7%
28
  80.0%
4.Primary Outcome
Title Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.
Hide Description Mean quantity of dialysis sessions per patient in the first 7 days post transplant.
Time Frame First 7 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: dialysis sessions
0.97  (1.22) 1.54  (1.54)
5.Secondary Outcome
Title Serum Creatinine
Hide Description Mean serum creatinine on day 90 in mg/dL
Time Frame Up to 90 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.3  (0.317) 1.7  (1.410)
6.Secondary Outcome
Title Creatinine Clearance
Hide Description Creatinine clearance calculated based on serum creatinine, milliliters per minute.
Time Frame Up to 90 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 34
Mean (Standard Deviation)
Unit of Measure: ml/minute
56.4  (15.558) 51.2  (17.335)
7.Secondary Outcome
Title 24h Urine Output
Hide Description 24 hour urine output post-transplantation measured in milliliters
Time Frame 24 hours post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: milliliters
873.5  (1257.0) 607.8  (782.4)
8.Secondary Outcome
Title Mean Number of Patients on Dialysis
Hide Description Mean number of patients on dialysis at 15 to 30 days post-transplant
Time Frame 15 to 30 days post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5
  14.3%
9.Secondary Outcome
Title Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)
Hide Description

DGF 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.

Time Frame First 7 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 34 35
Measure Type: Count of Participants
Unit of Measure: Participants
15
  44.1%
21
  60.0%
10.Other Pre-specified Outcome
Title Overall Incidence of Serious Adverse Events
Hide Description Overall incidence of serious adverse events in the C1INH and placebo groups, number of events.
Time Frame Up to 9 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: events
11 16
11.Other Pre-specified Outcome
Title Patient Survival
Hide Description Patient survival at 90 days post-transplantation
Time Frame Up to 90 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
35
 100.0%
35
 100.0%
12.Other Pre-specified Outcome
Title Rate of Acute Cellular Rejection (ACR)
Hide Description Number of acute cellular and antibody mediated rejection episodes by day 90.
Time Frame Up to 90 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: episodes
0 0
13.Other Pre-specified Outcome
Title Graft Survival
Hide Description Number of Participants with Graft Survival at 90 Days Post-Transplant
Time Frame Day 90 Post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
34
  97.1%
34
  97.1%
Time Frame Adverse event data collected up to 9 months post transplant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Hide Arm/Group Description

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

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

All-Cause Mortality
C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/35 (28.57%)      10/35 (28.57%)    
Cardiac disorders     
A fib, shortness of breath, chest pain   1/35 (2.86%)  1 0/35 (0.00%)  0
Right leg DVT   0/35 (0.00%)  0 1/35 (2.86%)  1
Upper extermity/facial swelling, SVC syndrome   0/35 (0.00%)  0 1/35 (2.86%)  1
A flutter   0/35 (0.00%)  0 1/35 (2.86%)  1
Afib/ventricular tachycardia   0/35 (0.00%)  0 1/35 (2.86%)  1
Hypertension   0/35 (0.00%)  0 1/35 (2.86%)  1
Non ST segment elevation   1/35 (2.86%)  1 0/35 (0.00%)  0
Endocrine disorders     
Diabetic Ketoacidosis   1/35 (2.86%)  1 0/35 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/35 (2.86%)  1 2/35 (5.71%)  2
Nausea/vomiting   0/35 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations     
Bacteremia   1/35 (2.86%)  1 0/35 (0.00%)  0
Neutropenia/Fever   1/35 (2.86%)  1 1/35 (2.86%)  1
Viral infection   1/35 (2.86%)  1 0/35 (0.00%)  0
Purulent Drainage from wound   1/35 (2.86%)  1 0/35 (0.00%)  0
Acute Encephalopathy   0/35 (0.00%)  0 1/35 (2.86%)  1
Sepsis from Urinary Tract Infection   0/35 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Slurred speech/weakness/fatigue   0/35 (0.00%)  0 1/35 (2.86%)  1
Renal and urinary disorders     
Elevated creatinine/edema   1/35 (2.86%)  1 0/35 (0.00%)  0
Nephrectomy due to poor perfusion   0/35 (0.00%)  0 1/35 (2.86%)  1
Urine Leak   0/35 (0.00%)  0 1/35 (2.86%)  1
Peri-renal transplant hematoma   0/35 (0.00%)  0 1/35 (2.86%)  1
Dysuria   0/35 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Flash pulmonary edema   1/35 (2.86%)  1 0/35 (0.00%)  0
Dyspnea on exertion   1/35 (2.86%)  1 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
C1-Inhibitor (Berinert) (Human) (C1INH) Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/35 (80.00%)      26/35 (74.29%)    
Cardiac disorders     
Hypertension   1/35 (2.86%)  1 7/35 (20.00%)  7
Edema   7/35 (20.00%)  7 4/35 (11.43%)  4
Hypotension   1/35 (2.86%)  1 2/35 (5.71%)  2
Shortness of Breath   1/35 (2.86%)  1 3/35 (8.57%)  3
Chest Pain   1/35 (2.86%)  1 2/35 (5.71%)  2
Endocrine disorders     
Hyperglycemia   2/35 (5.71%)  2 0/35 (0.00%)  0
Gastrointestinal disorders     
Constipation   3/35 (8.57%)  3 3/35 (8.57%)  3
Nausea   3/35 (8.57%)  3 7/35 (20.00%)  7
Vomiting   2/35 (5.71%)  2 3/35 (8.57%)  3
Abdominal Pain   2/35 (5.71%)  2 0/35 (0.00%)  0
General disorders     
Fatigue  [1]  2/35 (5.71%)  2 5/35 (14.29%)  5
Metabolism and nutrition disorders     
Hyperkalemia   7/35 (20.00%)  7 7/35 (20.00%)  7
Respiratory, thoracic and mediastinal disorders     
Cough   2/35 (5.71%)  2 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders     
Pruritis   2/35 (5.71%)  2 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Generalized fatigue described by the patient
The limitations of this study include the small sample size and single-center performance. However, the patient population was balanced between the two groups and donor organ characteristics, including implantation biopsies, were similar.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Noriko Ammerman, PharmD
Organization: Cedars-Sinai Medical Center
Phone: 310-248-8186
EMail: noriko.ammerman@cshs.org
Layout table for additonal information
Responsible Party: Stanley Jordan, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02134314    
Other Study ID Numbers: C1INH (Berinert) for DGF
IND15806 ( Other Identifier: FDA )
First Submitted: February 19, 2014
First Posted: May 9, 2014
Results First Submitted: March 13, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018