This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01147302
First received: June 16, 2010
Last updated: July 22, 2015
Last verified: March 2014
History of Changes
Results First Received: June 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Graft Rejection
Interventions: Biological: Placebo
Biological: C1 Esterase Inhibitor (Human)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
CINRYZE Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.

Participant Flow:   Overall Study
    Placebo   CINRYZE
STARTED   9   9 
COMPLETED   9   9 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat (ITT) population, defined as all participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).

Reporting Groups
  Description
Placebo Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
CINRYZE Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
Total Total of all reporting groups

Baseline Measures
   Placebo   CINRYZE   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 9   9   18 
Age 
[Units: Years]
Mean (Standard Deviation) 		 48.8  (13.0)   48.6  (12.5)   48.7  (12.4) 
Age, Customized 
[Units: Participants]
 		     
18 to 44 years   3   4   7 
45 to 64 years   4   4   8 
65 to 75 years   2   1   3 
Gender 
[Units: Participants]
 		     
Female   6   5   11 
Male   3   4   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Histopathology Endpoints   [ Time Frame: Within 72 hours prior to first dose of study drug, Day 20 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)   [ Time Frame: 90 days after start of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Serum Creatinine   [ Time Frame: From Day 1 to Days 20 and 90 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Creatinine Clearance   [ Time Frame: From Day 1 to Days 20 and 90 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Plasmapheresis Sessions   [ Time Frame: From Day 1 through Days 20 and 90 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Who Required Salvage Splenectomy   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Deaths   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Allograft Failure   [ Time Frame: From the day of enrollment to Day 90 ]
  Show Outcome Measure 8

9.  Secondary:   Serum Concentrations of C1 Inhibitor (C1 INH) Antigen   [ Time Frame: Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion ]
  Show Outcome Measure 9

10.  Secondary:   Serum Concentrations of C1 INH Functional Activity   [ Time Frame: Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion ]
  Show Outcome Measure 10

11.  Secondary:   Time to Maximum Plasma Concentration (Tmax) of C1 INH   [ Time Frame: Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion ]
  Show Outcome Measure 11

12.  Secondary:   Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen   [ Time Frame: Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion ]
  Show Outcome Measure 12

13.  Secondary:   Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity   [ Time Frame: Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion ]
  Show Outcome Measure 13


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01147302     History of Changes
Other Study ID Numbers: 0624-201
2012-000441-12 ( EudraCT Number )
Study First Received: June 16, 2010
Results First Received: June 16, 2015
Last Updated: July 22, 2015