Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Hectorol (doxercalciferol capsules), 0.5mcg
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility 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
Sites / Locations
- AKDHC Medical Research Services
- UCLA Diabetes Reseach Center
- Apex Research of Riverside
- George Washington University Hospital
- Discovery Medical Research Group
- Nephrology Associates
- Georgia Kidney Associates, Inc.
- Michigan Kidney Consultants, P.C.
- Twin Cities Clinical Research
- Montefiore Medical Center
- University of Rochester Medical Center
- Wake Nephrology Associates, PA
- Wake Forest University School of Medicine
- Altru Health System Research Center
- DaVita Lewiston Dialysis Center
- Temple University
- Virginia Commonwealth University
- Instituto Renal del Este
- Jose Cangiano, MD
Outcomes
Primary Outcome Measures
Laboratory measurement of intact parathyroid hormone (iPTH)
Secondary Outcome Measures
Laboratory measurement of serum bone markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00123461
Brief Title
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
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).
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hectorol (doxercalciferol capsules), 0.5mcg
Primary Outcome Measure Information:
Title
Laboratory measurement of intact parathyroid hormone (iPTH)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Laboratory measurement of serum bone markers
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
AKDHC Medical Research Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
UCLA Diabetes Reseach Center
City
Alhambra
State/Province
California
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Nephrology Associates
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Georgia Kidney Associates, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Michigan Kidney Consultants, P.C.
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Twin Cities Clinical Research
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Nephrology Associates, PA
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Altru Health System Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
DaVita Lewiston Dialysis Center
City
Lewiston
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Instituto Renal del Este
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Jose Cangiano, MD
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
12. IPD Sharing Statement
Links:
URL
http://www.hectorol.com/docs/Hectorol%20Capsule%20PI%20Text_2006-01.pdf
Description
US FDA Approved Full Prescribing Information for Hectorol® Capsules
Learn more about this trial
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
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