Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism - Tabular View

Tracking Information

First Received Date ^ICMJE

July 21, 2005

Last Updated Date

July 28, 2009

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Laboratory measurement of intact parathyroid hormone (iPTH) [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Laboratory measurement of iPTH

Change History

Complete list of historical versions of study NCT00123461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Laboratory measurement of serum bone markers [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Laboratory measurement of serum bone markers

Descriptive Information

Brief Title ^ICMJE

Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

Official Title ^ICMJE

A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Secondary Hyperparathyroidism
Renal Failure
Chronic Renal Insufficiency

Intervention ^ICMJE

Drug: Hectorol (doxercalciferol capsules), 0.5mcg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4
Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min

Exclusion Criteria:

Serum cCa > 9.5 mg/dL
Serum P > 4.6 mg/dL
Abnormal liver functions
Anticipated requirement for maintenance hemodialysis
Use of active vitamin D sterol therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00123461

Responsible Party

Medical Monitor, Genzyme Corporation

Study ID Numbers ^ICMJE

BCI-CH-151

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP