Therapeutic Area
Nephrology
About Rayaldee®
Rayaldee® (calcifediol) is an extended-release prohormone of the active form of vitamin D3 that both raises 25-hydroxyvitamin D and lowers intact parathyroid hormone (iPTH) levels in patients with stage 3 or 4 CKD. Rayaldee® is under development for adult patients with stage 5 chronic kidney disease (CKD) with SHPT and vitamin D insufficiency who require regular dialysis.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a worldwide public health problem with steadily increasing incidence, prevalence, and cost. Key factors driving CKD in developed countries include aging populations and the current epidemic of obesity and its associated complications of hypertension and adult-onset diabetes.
In the United States, there are currently approximately 37 million adults with CKD according to the National Kidney Foundation (NFK), about 17 million of whom suffer from moderate CKD (stages 3 and 4) to severe CKD (stage 5). Stages 3 and 4 are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In stage 5, kidney function is minimal to altogether absent, and patients require regular dialysis or kidney transplant for survival. An estimated 71-97% of CKD patients have vitamin D insufficiency, which can lead to secondary hyperparathyroidism (SHPT) and resultant debilitating diseases including bone disease, markedly increased bone fracture rates, pervasive soft tissue calcification, cardiovascular disease, muscle weakness and reduced quality of life.