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A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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.

NCT00463021•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (8)

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

Key Dates

Start Date

April 1, 2007

Completion Date

December 1, 2007

Last Updated

May 5, 2015

Enrollment

ESTIMATED participants

Conditions

Secondary Hyperparathyroidism

Interventions

Hectorol (doxercalciferol capsules)

DRUG

Zemplar (paricalcitol injection)

DRUG

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

NCT03633708

Secondary HyperparathyroidismChronic Kidney Disease

View study

RECRUITINGNA

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

NCT04922892

Secondary Hyperparathyroidism;Parathyroidectomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT