Hectorol^® (doxercalciferol)

Bibliographical Information:

Drug Name	Generic Name	Therapeutic Area and FDA Approved Indications:	Approved U.S. Drug Label
Hectorol®	doxercalciferol	Chronic Kidney Disease CAPSULES: Dialysis Patients: Hectorol® is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Pre-Dialysis Patients: Hectorol® is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease. INJECTIONS: Hectorol® is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.	Hectorol® Capsules Hectorol® Injections

Protocol BCI-CH-101:
Gallagher JC, Bishop CW, Knutson JC, et al., Effects of Increasing Doses of 1α -Hydroxyvitamin D₂ on Calcium Homeostasis in Postmenopausal Osteopenic Women. J. Bone Miner. Res. 1994; 9(5): 607-614.

Protocol BCI-CH-102:
Gallagher JC, Bishop CW, Kyllo DM, et al. Effect of 1α OHD₂ on Spinal and Femoral Neck Bone in Postmenopausal Osteoporosis. J. Bone Miner. Res. 1993; 8: S260.

Gallagher JC, Bishop CW, Kyllo DM, et al. Long-term Evaluation of the Safety of 1α OHD₂ in Postmenopausal Women. J. Bone Miner. Res. 1993; 8: S330.

Protocol BCI-CH-106:
Frazão JM, Levine BS, Tan AU, et al. Efficacy and safety of intermittent oral 1α (OH)-vitamin D₂) in suppressing 2^o hyperparathyroidism in hemodialysis patients. Dialysis and Transplantation, 1997; 26: 583-590.

Tan AU Jr., Levine, BS, Mazess, RB, et al., Effective Suppression of Parathyroid Hormone by 1α-Hydroxyvitamin D₂ in Hemodialysis Patients with Moderate to Severe Secondary Hyperparathyroidism. Kidney Int 1997; 51: 317-323.

Protocol BCI-CH-108 LA:
Frazão JM, Chesney RW, Coburn JW, and the 1α D₂ Study Group. Intermittent oral 1α -hydroxyvitamin D₂ is effective and safe for the suppression of secondary hyperparathyroidism in hemodialysis patients. Nephrol. Dial. Transplant. 1998; 13 (suppl 13): 68-72.

Frazão JM, Elangovan L, Maung, HM, et al. Intermittent Doxercalciferol (1α -Hydroxyvitamin D₂) Therapy for Secondary Hyperparathyroidism. Am. J. Kid. Dis. 2000; 36(3): 550-561.

Protocol BCI-CH-108 Memphis:
Frazão JM, Chesney RW, Coburn JW, and the 1α D₂ Study Group. Intermittent oral 1α-hydroxyvitamin D₂ is effective and safe for the suppression of secondary hyperparathyroidism in haemodialysis patients. Nephrol. Dial. Transplant. 1998; 13 (suppl 13): 68-72.

Frazão JM, Elangovan L, Maung, HM, et al. Intermittent Hectorol^® (1α-Hydroxyvitamin D₂) Therapy for Secondary Hyperparathyroidism. Am. J. Kid. Dis. 2000; 36(3): 550-561.

Protocol BCI-CH-110:
Frazão JM, Levine BS, Tan AU, et al. Efficacy and Safety of Intermittent Oral 1α (OH)-Vitamin D₂) in Suppressing 2^o Hyperparathyroidism in Hemodialysis Patients. Dialysis and Transplantation, 1997; 26: 583-590.

Protocol BCI-CH-112:
No associated publications

Protocol BCI-CH-113:
Liu G, Oettek K, Ripple G, et al. Phase 1 Trial of 1-α -Hydroxyvitamin D₂ in Patients with Hormone Refractory Prostate Cancer. Clin Cancer Res 2002; 8: 2820-2827.

Protocol BCI-CH-114 LA:
Maung HM, Elangovan L, Frazão JM, et al. Efficacy and Side Effects of Intermittent Intravenous and Oral Doxercalciferol (1α-Hydroxyvitamin D₂) in Dialysis Patients with Secondary Hyperparathyroidism: A sequential Comparison. Am. J. Kid. Dis. 2001; 37(3): 532-543.

Protocol BCI-CH-114 Memphis:
Maung HM, Elangovan L, Frazão JM, et al. Efficacy and Side Effects of Intermittent Intravenous and Oral Doxercalciferol (1α-Hydroxyvitamin D₂) in Dialysis Patients with Secondary Hyperparathyroidism: A Sequential Comparison. Am. J. Kid. Dis. 2001; 37(3): 532-543.

Protocol BCI-CH-115:
Coburn JW, Maung HM, Elangovan L. et al. Doxercalciferol Safely Suppresses PTH Levels in Patients with Secondary Hyperparathyroidism Associated with Chronic Kidney Disease Stages 3 and 4. Am. J. Kid. Dis. 2004; 43(5): 877-890.

Protocol BCI-CH-119:
Coburn JW, Maung HM, Elangovan L. et al. Doxercalciferol Safely Suppresses PTH Levels in Patients with Secondary Hyperparathyroidism Associated with Chronic Kidney Disease Stages 3 and 4. Am. J. Kid. Dis. 2004; 43(5): 877-890.

Protocol BCI-CH-120:
No associated publications

Protocol BCI-CH-125:
Liu G, Wilding G, Staab MJ, et al. Phase II Study of 1-α -Hydroxyvitamin D₂ in the Treatment of Advanced Androgen-Independent Prostate Cancer. Clin Cancer Res 2003; 9: 4077-4083.

Protocol BCI-CH-126:
No associated publications

Protocol BCI-CH-144:
Zisman A, Ghantous W, Schinleber P, et al. Inhibition of Parathyroid Hormone: A Dose Equivalency Study of Paricalcitol and Doxercalciferol, Am J of Nephrol. 2005; 25:591-595.