Real-World Doxercalciferol Treatment in SHPT CKD Stage 3 and 4: An Analysis of Change in iPTH and Accordance to KDOQI Recommendations

Abstract

Background: National Kidney Foundation’s Kidney Disease Outcome Quality Initiative (KDOQI) guidelines offer an outline for providing standardized care for best outcomes in chronic kidney disease (CKD). It is unknown whether real-world treatment practices follow these guidelines. Methods: The Hectorol® Registry Outcome in Chronic Kidney Disease (HeROICkd™), an observational patient registry, captured information on adult patients with CKD Stage 3 or 4 throughout US clinics during a 9-month observation period. Data were collected quarterly from patients’ medical records, throughout each patient’s normal treatment course. The proportion of patients with intact parathyroid hormone (iPTH) levels within KDOQI guidelines, change in iPTH, Ca, P, and Ca × P product over the 9-month observation period, incidence of hypercalcemia and hyperphosphatemia, and predictors of change in iPTH were examined. Results: 1,339 CKD Stage 3 and 4 patients from 78 nephrology and internal medicine clinics were included. 40% of CKD Stage 3 participants and 45% of Stage 4 had a 30% or greater reduction in iPTH levels from baseline to 9 months follow-up. While the proportion of CKD Stage 3 and 4 participants with iPTH levels within the KDOQI recommendations improved significantly over the 9 months, it was still modest, at 28% and 23%, respectively. Mean doxercalciferol dose was below that recommended in the package insert and a minority of patients had all mineral metabolism parameters (iPTH, Ca, P) regularly recorded in their medical records. Conclusions: The results of this registry, which examined iPTH treatment with doxercalciferol in CKD Stage 3 and 4, suggest that in the real-world treatment setting, the adherence to KDOQI guidelines is not optimal.