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A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis

NCT00418600•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

Summary

Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.

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 Hectorol 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.
•Current use of aluminum or magnesium based binders.

Locations (8)

Hot Springs, Arkansas, United States

Downey, California, United States

Tarzana, California, United States

Atlanta, Georgia, United States

Cincinnati, Ohio, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Spokane, Washington, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

June 1, 2007

Completion Date

August 1, 2007

Last Updated

March 19, 2015

Enrollment

ACTUAL participants

Conditions

Secondary Hyperparathyroidism

Interventions

Hectorol® (doxercalciferol capsules)

DRUG

doxercalciferol capsules, Hectorol®

DRUG

doxercalciferol capsules, Hectorol® capsules

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

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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: March 19, 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.

View ClinicalTrials.gov Terms and Conditions

A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

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