NCT00418600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

January 3, 2007

Last Update Submit

March 17, 2015

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary HyperparathyroidismHectorol® (doxercalciferol capsules)Hectorol® (doxercalciferol injection)

Outcome Measures

Primary Outcomes (1)

  • Dose Conversion

    5 weeks

Study Arms (3)

1

OTHER

Hectorol capsules at 1.0 times current injection dose

Drug: Hectorol® (doxercalciferol capsules)

2

OTHER

Hectorol capsules at 1.5 times current injection dose

Drug: doxercalciferol capsules, Hectorol®

3

OTHER

Hectorol capsules at 2.0 times current injection dose

Drug: doxercalciferol capsules, Hectorol® capsules

Interventions

Hectorol® (doxercalciferol capsules)DRUG

Hectorol capsules at 1.0 times current injection dose

1
doxercalciferol capsules, Hectorol®DRUG

Hectorol capsules at 1.5 times current injection dose

2
doxercalciferol capsules, Hectorol® capsulesDRUG

Hectorol capsules at 2.0 times current injection dose

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Downey, California, United States

Location

Unknown Facility

Tarzana, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

August 1, 2007

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

US(8)