OCT launches a multicentre phase IIA/III study of a novel biological agent to treat anemia in chronic kidney disease including 120 subjects in Russia. Total 8 sites will be initiated. Our medical writers are in the process of study documents design and study is being prepared for startup. We have everything necessary to get this study started quickly and efficiently including a skilled research team, experienced investigators and an extensive recruitment list. A central laboratory will be used to evaluate the safety and efficacy of the study drug.
Chronic kidney disease is a progressive loss of kidney function during a period of months or years that can be caused by a number of conditions, such as diabetes and high blood pressure. It is a highly prevalent condition worldwide with numbers expected to rise over the next decade. CKD affects more than 20 million people in Russia and millions more in the rest of the world.
Anemia is a frequent complication of chronic kidney disease. Studies have shown that anemia is associated with an increased risk of mortality and cardiovascular morbidity in CKD patients. The optimal treatment of anemia in patients with CKD is of increasing importance, since early and adequate treatment of anemia may have a positive impact on mortality in this patient population.
In nature, the amount of oxygen in the blood determines how fast red cells are produced. Low oxygen level in kidney cells stimulates the genes inside their center to synthesize the hormone (erythropoietin) necessary to turn on the bone marrow so it can produce red blood cells. As the kidney becomes diseased, mechanisms that form scar tissue take over, and cells responsible for manufacturing erythropoietin die. Usually anemia starts in the third stage of kidney disease worsening as kidney disease progresses. In most cases, the cause of anemia in kidney disease is the result of decreased production of erythropoietin. Once the diagnosis of anemia in chronic kidney disease is made, the therapy includes injections of the synthetic form of erythropoietin.
OCTs wide network of investigative sites specialized in the nephrology therapy area, and close relationships with these sites provides us with confidence that study is to be completed on time and within the budget.