Kamada has enrolled the first participant in an investigator-initiated clinical trial of Cytogam (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) to prevent late CMV infection in kidney transplant recipients.
Despite recent advancements in antiviral therapies, CMV infection continues to pose a significant medical challenge that remains inadequately addressed.
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The post-marketing Strategic Help with Immunoglobulin to Enhance protection against Late Disease (CMV) (SHIELD) study is a controlled multicentre, randomised, prospective trial investigating the therapy in the high-risk transplant recipients.
CMV is an opportunistic infection that can affect transplant recipients as a result of anti-rejection medications, which suppress the immune system.
Typically, transplant recipients are administered prophylactic antiviral medications during the initial months post-transplant, when the immunosuppressive treatment is at its most intense.
The trial will investigate the advantages of administering Cytogam at the end of antiviral prophylaxis to minimise clinically significant late CMV risk in kidney transplant recipients.
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By GlobalDataThese recipients are CMV seronegative and have seropositive donors.
Camille Kotton, an infectious disease specialist and clinical director of Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital, along with David Wojciechowski, medical director of the Kidney Transplantation Program at the University of Texas Southwestern Medical Center, are conducting the study.
Kamada CEO Amir London said: “Up to one third of kidney transplant patients may develop late CMV infection or disease after stopping initial anti-viral prophylaxis therapy.
“Cytogam is a critical life-saving therapeutic, and our support for this study further underscores Kamada’s commitment to serving the transplant community. We look forward to the results of this important post-marketing trial, led by two distinguished thought leaders in Drs Kotton and Wojciechowski.”
The intravenous immunoglobulin is indicated for the prophylaxis of cytomegalovirus disease in patients undergoing heart, kidney, liver, lung and pancreas transplantation.
