- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463021
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
May 4, 2015 updated by: Genzyme, a Sanofi Company
A Phase 4, Multi Center, Open-Label, Randomized Study 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 (CKD) Subjects on Hemodialysis.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Downey, California, United States
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Paramount, California, United States
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Florida
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Hudson, Florida, United States
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Georgia
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Augusta, Georgia, United States
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Decatur, Georgia, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Tennessee
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Nashville, Tennessee, United States
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Virginia
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Norfolk, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must be receiving hemodialysis three times per week for a minimum of six months.
- The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
Exclusion Criteria:
- In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose Conversion
Time Frame: 10 weeks
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10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
April 18, 2007
First Submitted That Met QC Criteria
April 18, 2007
First Posted (Estimate)
April 19, 2007
Study Record Updates
Last Update Posted (Estimate)
May 5, 2015
Last Update Submitted That Met QC Criteria
May 4, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HECT00306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Secondary Hyperparathyroidism
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Chang Gung Memorial HospitalCompletedSecondary Hyperparathyroidism Due to Renal CausesTaiwan
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Sanwa Kagaku Kenkyusho Co., Ltd.Completed
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Sanwa Kagaku Kenkyusho Co., Ltd.CompletedSecondary HyperparathyroidismJapan
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Deltanoid PharmaceuticalsCompletedSecondary HyperparathyroidismUnited States
Clinical Trials on Zemplar (paricalcitol injection)
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Dr. Reddy's Laboratories LimitedCompleted
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AbbVie (prior sponsor, Abbott)Massachusetts General HospitalCompletedChronic Kidney Disease | Left Ventricular HypertrophyUnited States, Australia, Czech Republic, Germany, Italy, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom
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AbbottCompletedDiabetic Nephropathy | Chronic Kidney DiseaseUnited States, Germany, Greece, Italy, Netherlands, Poland, Portugal, Puerto Rico, Spain, Taiwan
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AbbVie (prior sponsor, Abbott)CompletedChronic Kidney Disease Stage 3 and 4
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AbbottCompletedSecondary Hyperparathyroidism | Chronic Kidney Disease, Stage 5United States
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AbbottCompletedSecondary Hyperparathyroidism | DialysisMexico
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AbbottCompletedChronic Kidney DiseaseChina
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The University of Hong KongAbbottCompleted
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Genzyme, a Sanofi CompanyCompletedSecondary HyperparathyroidismUnited States
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AbbottCompletedRenal Insufficiency, Chronic | Hemodialysis | Secondary Hyperparathyroidism | Hypercalcemia | Parathyroid HormonePeru