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Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123461
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : May 5, 2015
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Renal Failure Chronic Renal Insufficiency Drug: Hectorol (doxercalciferol capsules), 0.5mcg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).
Study Start Date : July 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Laboratory measurement of intact parathyroid hormone (iPTH) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Laboratory measurement of serum bone markers [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4
  • Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
  • CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min

Exclusion Criteria:

  • Serum cCa > 9.5 mg/dL
  • Serum P > 4.6 mg/dL
  • Abnormal liver functions
  • Anticipated requirement for maintenance hemodialysis
  • Use of active vitamin D sterol therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123461


Locations
Show Show 19 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Additional Information:
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Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00123461    
Other Study ID Numbers: BCI-CH-151
First Posted: July 25, 2005    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
1 alpha-hydroxyergocalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents