Kamada Ltd. has announced the enrollment of the first patient in the SHIELD trial, a post-marketing clinical study investigating CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) for preventing late cytomegalovirus infection in kidney transplant recipients. The investigator-initiated trial addresses a significant unmet medical need in transplant care, where up to one-third of kidney transplant patients may develop late CMV infection after stopping initial antiviral prophylaxis therapy.
Study Design and Patient Population
The SHIELD study, formally titled "Strategic Help with Immunoglobulin to Enhance protection against Late Disease (CMV)," is designed as a prospective, randomized, controlled multicenter trial. The study specifically targets CMV high-risk kidney transplant recipients who are CMV seronegative and have received organs from CMV seropositive donors. This patient population represents the highest risk group for developing late-onset CMV infection, which is associated with worse transplant recipient health and outcomes.
The trial will investigate the benefits of CYTOGAM administered at the conclusion of antiviral prophylaxis to reduce the risk of clinically significant late CMV disease. CMV disease is an opportunistic infection that can occur in transplant recipients due to anti-rejection medications that weaken the immune system, with anti-rejection medication typically being most intense in the first few months after transplant.
Expert Leadership and Clinical Rationale
The study is being conducted by leading experts in CMV and organ transplantation: Dr. Camille Kotton, Infectious Disease Specialist and Clinical Director of Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital, and Dr. David Wojciechowski, Medical Director of the Kidney Transplantation Program at the University of Texas Southwestern Medical Center. Both investigators are recognized experts in transplant-related infections.
In a joint statement, Drs. Kotton and Wojciechowski emphasized the clinical significance of the research: "CMV disease is a leading cause for organ dysfunction and severe transplantation complications. There is a significant need in post-operative transplant care for rigorous scientific exploration of innovative prophylactic approaches for decreasing the risk of late CMV infection and improving transplant patient outcomes."
CYTOGAM Therapeutic Profile
CYTOGAM is an intravenous immunoglobulin containing standardized amounts of antibody to cytomegalovirus. The therapy is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.
Company Perspective and Market Impact
Amir London, Kamada's Chief Executive Officer, highlighted the clinical importance of the research: "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 trial represents part of Kamada's broader strategy as a global biopharmaceutical company specializing in plasma-derived therapies for rare and serious conditions. The company maintains a portfolio of six FDA-approved specialty plasma-derived products, including CYTOGAM, and operates three plasma collection centers in Texas to support its manufacturing operations.
