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

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00123461

Purpose

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.

Condition	Intervention	Phase
Secondary Hyperparathyroidism Renal Failure Chronic Renal Insufficiency	Drug: Hectorol (doxercalciferol capsules), 0.5mcg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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).

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	July 2005
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123461

Locations

United States, Arizona
AKDHC Medical Research Services
Phoenix, Arizona, United States, 85012
United States, California
UCLA Diabetes Reseach Center
Alhambra, California, United States
Apex Research of Riverside
Riverside, California, United States, 92501
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Florida
Nephrology Associates
Palm Beach Gardens, Florida, United States, 33410
Discovery Medical Research Group
Ocala, Florida, United States, 34471
United States, Georgia
Georgia Kidney Associates, Inc.
Marietta, Georgia, United States, 30060
United States, Michigan
Michigan Kidney Consultants, P.C.
Pontiac, Michigan, United States, 48341
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, New York
Montefiore Medical Center
Bronx, New York, United States
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States
United States, North Dakota
Altru Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States
DaVita Lewiston Dialysis Center
Lewiston, Pennsylvania, United States, 17044
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States
Puerto Rico
Jose Cangiano, MD
San Juan, Puerto Rico, 00918
Instituto Renal del Este
Caguas, Puerto Rico, 00725

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

Additional Information:

US FDA Approved Full Prescribing Information for Hectorol® Capsules This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	BCI-CH-151
Study First Received:	July 21, 2005
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00123461 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Ergocalciferol
Ergocalciferols
Kidney Failure, Chronic
Endocrine System Diseases
Bone Density Conservation Agents
Trace Elements
Hyperparathyroidism, Secondary
Vitamin D
1 alpha-hydroxyergocalciferol

Vitamin D2
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Neoplasm Metastasis
Calciferol
Micronutrients
Kidney Diseases
Endocrinopathy
Kidney Failure

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Kidney Failure, Chronic
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hyperparathyroidism, Secondary
Neoplastic Processes

Neoplasms
1 alpha-hydroxyergocalciferol
Pathologic Processes
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Neoplasm Metastasis
Micronutrients
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on August 28, 2009