Clinical trial NCT00123461: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Renal Failure
Chronic Renal Insufficiency
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-07-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Laboratory measurement of intact parathyroid hormone (iPTH)
timeFrame: 6 months
Secondary outcomes:
measure: Laboratory measurement of serum bone markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AKDHC Medical Research Services
state: Arizona
city: Alhambra
country: United States
facility: UCLA Diabetes Reseach Center
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Palm Beach Gardens
country: United States
facility: Nephrology Associates
state: Florida
city: Marietta
country: United States
facility: Georgia Kidney Associates, Inc.
state: Georgia
city: Pontiac
country: United States
facility: Michigan Kidney Consultants, P.C.
state: Michigan
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Nephrology Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Research Center
state: North Dakota
city: Lewiston
country: United States
facility: DaVita Lewiston Dialysis Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Caguas
country: Puerto Rico
facility: Instituto Renal del Este
city: San Juan
country: Puerto Rico
facility: Jose Cangiano, MD
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: