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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR DOXERCALCIFEROL

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Clinical Trials for Doxercalciferol

Trial ID Title Status Sponsor Phase Summary
NCT00123461 Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism Completed Genzyme, a Sanofi Company Phase 4 The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
NCT00285467 Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Completed Indiana University School of Medicine N/A The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.
NCT00418600 A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis Completed Genzyme, a Sanofi Company Phase 4 Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
NCT00454350 A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis Completed Genzyme, a Sanofi Company Phase 4 This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
NCT00463021 A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection Completed Genzyme, a Sanofi Company Phase 4 Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
NCT00511017 Doxercalciferol in Recurrent Pediatric Solid Tumors Terminated M.D. Anderson Cancer Center Phase 1 The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
NCT00528788 How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis Completed Genzyme, a Sanofi Company Phase 4 Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Doxercalciferol

Condition Name

Condition Name for Doxercalciferol
Intervention Trials
Secondary Hyperparathyroidism 7
Chronic Kidney Disease 3
Chronic Renal Insufficiency 2
Renal Osteodystrophy 2
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Condition MeSH

Condition MeSH for Doxercalciferol
Intervention Trials
Hyperparathyroidism, Secondary 11
Hyperparathyroidism 11
Kidney Diseases 6
Renal Insufficiency, Chronic 5
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Clinical Trial Locations for Doxercalciferol

Trials by Country

Trials by Country for Doxercalciferol
Location Trials
United States 55
Malaysia 7
Puerto Rico 1
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Trials by US State

Trials by US State for Doxercalciferol
Location Trials
California 5
Pennsylvania 4
Georgia 4
Texas 4
Tennessee 3
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Clinical Trial Progress for Doxercalciferol

Clinical Trial Phase

Clinical Trial Phase for Doxercalciferol
Clinical Trial Phase Trials
Phase 4 8
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Doxercalciferol
Clinical Trial Phase Trials
Completed 11
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for Doxercalciferol

Sponsor Name

Sponsor Name for Doxercalciferol
Sponsor Trials
Genzyme, a Sanofi Company 7
Sanofi 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for Doxercalciferol
Sponsor Trials
Other 11
Industry 10
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Queensland Health
Healthtrust
UBS
Chinese Patent Office
Chubb
Cantor Fitzgerald
Mallinckrodt
Citi

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