At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Placebo +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and C1 Esterase Inhibitor (Human) for Graft Rejection. Completed, enrolled 18 participants across 5 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Rejection
CountriesGermany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartAug 2011
Primary CompletionApr 2013
Study CompletionJun 2013
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartAug 24, 2011
Primary CompletionApr 19, 2013
Study CompletionJun 28, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.0 years ago
Interventions
Placebobiological
C1 Esterase Inhibitor (Human)biological