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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondary Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hectorol (doxercalciferol capsules)

Intervention Type DRUG

Zemplar (paricalcitol injection)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No