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CompletedNCT00463021Updated May 5, 2015

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

A Phase 4 interventional study of Hectorol (doxercalciferol capsules) and Zemplar (paricalcitol injection) in Secondary Hyperparathyroidism, sponsored by Genzyme, a Sanofi Company. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by Genzyme, a Sanofi Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Secondary Hyperparathyroidism

Keywords

  • Hectorol (doxercalciferol capsules)
  • Zemplar (paricalcitol injection)
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 36 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Interventions

  • DrugHectorol (doxercalciferol capsules)
  • DrugZemplar (paricalcitol injection)
06

What researchers measure

Primary outcomes

  1. Dose Conversion

    Time frame: 10 weeks

07

Study locations

8 sites
  • Downey, California, United States
  • Paramount, California, United States
  • Hudson, Florida, United States
  • Augusta, Georgia, United States
  • Decatur, Georgia, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Norfolk, Virginia, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00463021
Lead sponsor
Genzyme, a Sanofi Company
First posted
Apr 19, 2007
Start date
Apr 2007
Completion
Dec 2007
Last update
May 5, 2015

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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