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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00123461
First received: July 21, 2005
Last updated: July 28, 2009
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by Genzyme, a Sanofi Company:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Discovery Medical Research Group
Ocala, Florida, United States, 34471
Nephrology Associates
Palm Beach Gardens, Florida, United States, 33410
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 Nephrology Associates, PA
Raleigh, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
United States, North Dakota
Altru Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Pennsylvania
DaVita Lewiston Dialysis Center
Lewiston, Pennsylvania, United States, 17044
Temple University
Philadelphia, Pennsylvania, United States
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States
Puerto Rico
Instituto Renal del Este
Caguas, Puerto Rico, 00725
Jose Cangiano, MD
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

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

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Neoplasm Metastasis
Renal Insufficiency
Renal Insufficiency, Chronic
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Urologic Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014