Trials / Completed
CompletedNCT01147302
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
A Randomized Double-Blind Placebo-Controlled Pilot Study to Evaluate the Safety and Effect of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-Mediated Rejection in Recipients of Donor-Sensitized Kidney Transplants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | |
| BIOLOGICAL | C1 Esterase Inhibitor (Human) |
Timeline
- Start date
- 2011-08-24
- Primary completion
- 2013-04-19
- Completion
- 2013-06-28
- First posted
- 2010-06-22
- Last updated
- 2021-06-11
- Results posted
- 2015-07-09
Locations
5 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT01147302. Inclusion in this directory is not an endorsement.