A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
![]() |
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: NCT01147302 |
Recruitment Status :
Completed
First Posted : June 22, 2010
Results First Posted : July 9, 2015
Last Update Posted : August 13, 2015
|
Sponsor:
Shire
Information provided by (Responsible Party):
Shire
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Graft Rejection |
Interventions |
Biological: Placebo Biological: C1 Esterase Inhibitor (Human) |
Enrollment | 18 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | CINRYZE |
---|---|---|
![]() |
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. | 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. |
Period Title: Overall Study | ||
Started | 9 | 9 |
Completed | 9 | 9 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | CINRYZE | Total | |
---|---|---|---|---|
![]() |
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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 9 | 9 | 18 | |
![]() |
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).
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 9 participants | 9 participants | 18 participants | |
48.8 (13.0) | 48.6 (12.5) | 48.7 (12.4) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 9 participants | 9 participants | 18 participants |
18 to 44 years | 3 | 4 | 7 | |
45 to 64 years | 4 | 4 | 8 | |
65 to 75 years | 2 | 1 | 3 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 9 participants | 9 participants | 18 participants | |
Female |
6 66.7%
|
5 55.6%
|
11 61.1%
|
|
Male |
3 33.3%
|
4 44.4%
|
7 38.9%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: | Study Physician |
Organization: | Shire Development LLC |
Phone: | +1 866 842 5335 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01147302 |
Other Study ID Numbers: |
0624-201 2012-000441-12 ( EudraCT Number ) |
First Submitted: | June 16, 2010 |
First Posted: | June 22, 2010 |
Results First Submitted: | June 16, 2015 |
Results First Posted: | July 9, 2015 |
Last Update Posted: | August 13, 2015 |