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

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).

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Secondary Hyperparathyroidism; Chronic Renal Insufficiency
• Intervention / Treatment: Drug: Hectorol (doxercalciferol capsules), 0.5mcg

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Laboratory measurement of intact parathyroid hormone (iPTH)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Laboratory measurement of serum bone markers	6 months

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Publications and helpful links

Helpful Links

• US FDA Approved Full Prescribing Information for Hectorol® Capsules

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 21, 2005
• First Submitted That Met QC Criteria: July 21, 2005
• First Posted (Estimate): July 25, 2005

Study Record Updates

• Last Update Posted (Estimate): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Diseases; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Renal Insufficiency; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; 1 alpha-hydroxyergocalciferol
• Other Study ID Numbers: BCI-CH-151