Original Report: Patient-Oriented, Translational Research

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis
Edward A. Ross^a, Jin Tian^b, Hanna Abboud^c, Richard Hippensteel^b, Joel Z. Melnick^b, Rajendra S. Pradhan^b, Laura A. Williams^b, L. Lee Hamm^d, Stuart M. Sprague<sup>e

a</sup>Division of Nephrology, Hypertension, and Transplantation, University of Florida, Gainesville, Fla.,
^bAbbott Laboratories, Abbott Park, Ill.,
^cDivision of Nephrology, University of Texas Health Science Center, San Antonio, Tex.,
^dSection of Nephrology and Hypertension, Tulane University School of Medicine, New Orleans, La., and
^eDivision of Nephrology and Hypertension, Evanston Northwestern Healthcare Northwestern University Feinberg School of Medicine, Evanston, Ill., USA

Address of Corresponding Author

Am J Nephrol 2008;28:97-106 (DOI: 10.1159/000109398)

  Key Words

• Paricalcitol
• Secondary hyperparathyroidism
• Chronic renal failure
• Chronic renal insufficiency

  Abstract

Background/Aims: Secondary hyperparathyroidism is a common complication of chronic kidney disease, resulting from inactivation of vitamin D receptor signaling and phosphate retention. Selective activation of vitamin D receptors with intravenous paricalcitol significantly reduced parathyroid hormone (PTH) levels with no significant hypercalcemia or hyperphosphatemia in predialysis and hemodialysis (HD) patients. This study investigates the effects of oral paricalcitol to reduce PTH in patients receiving chronic HD and peritoneal dialysis (PD). Methods: Eighty-eight patients were randomized in double-blind fashion to receive paricalcitol or placebo for 12 weeks. The dose of the study drug was adjusted weekly using the previous week's intact PTH (iPTH) level as well as calcium and Ca × P product levels. The primary end points were efficacy (two consecutive iPTH decreases of 30%) and safety (two consecutive calcium measurements >11.0 mg/dl). Markers of biochemical bone activity were followed. Results: Demographic characteristics were similar between treatment groups. The mean paricalcitol doses (three times a week) over the entire treatment period for subjects with baseline iPTH 500 pg/ml and iPTH >500 pg/ml were 3.9 and 7.6 µg, respectively. A statistically significant decrease in iPTH was seen after week 1, with a mean 30% reduction occurring by week 3. A significantly greater proportion of both HD and PD paricalcitol subjects [83% (33/40) and 100% (18/18), respectively] achieved two consecutive 30% decreases in iPTH. The treatment groups were not statistically different in regard to the hypercalcemia safety end point. Phosphate binder use and mean serum phosphorus levels were not different between the treatment groups. The markers of bone activity improved in the treated subjects and worsened in those on placebo. Conclusion: Paricalcitol provides a rapid and sustained reduction of PTH in both HD and PD patients with minimal effect on serum calcium and phosphorus and no significant difference in adverse events as compared with placebo.

Copyright © 2007 S. Karger AG, Basel

  Author Contacts

Edward A. Ross, MD
Division of Nephrology, Hypertension, and Transplantation
University of Florida, Box 100224
Gainesville, FL 32610-0224 (USA)
Tel. +1 352 392 4007, Fax +1 352 392 3581, E-Mail Rossea@medicine.ufl.edu

  Article Information

Conflicts of Interest: E.A.R., L.L.H., and S.M.S. have received speaker's honoraria from Abbott Laboratories; J.T., R.H., J.Z.M., R.S.P., and L.A.W. are employees of Abbott Laboratories.

Received: June 15, 2007
Accepted: August 15, 2007
Published online: October 3, 2007
Number of Print Pages : 10
Number of Figures : 4, Number of Tables : 4, Number of References : 19