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Clinical trial

A Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Patients With Kidney Transplant

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Last updated:1st Oct 2015

To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) within 6 months.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated Rejection in Kidney Transplant Patients
Estimated Enrollment: 112
Study Start Date: October 2015
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Cinryze®
- Placebo Comparator: Placebo

Category Value
Study start date 2015-10-01

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