Date: 2015-10-13
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Shire (UK - USA)
Product: Cinryze®
Action
mechanism: enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema. Cinryze® is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks. Cinryze® was developed by Viropharma that has been acquired by Shire in 2014.
Disease: acute antibody-mediated rejection in kidney transplant patients
Therapeutic area: Transplantation - Renal diseases - Kidney diseases
Country: USA
Trial
details: This randomized double-blind placebo-controlled study will 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. (NCT02547220)
Latest
news: * On October 13, 2015, Shire announced that the FDA has granted Fast Track designation for the investigation of Cinryze® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients. The company also announced that it is planning a Phase 3 multi-center, multi-national, randomized, double-blind, placebo-controlled study (SHP616-302) to evaluate the efficacy of Cinryze® (intravenous administration) as an adjunct to DSA reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) for the treatment of acute AMR in kidney transplant recipients. The trial will be conducted in the United States, Europe and Canada and the study will open for enrollment by the end of October 2015.
