NCT00123461

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

July 21, 2005

Last Update Submit

May 4, 2015

Conditions

Secondary HyperparathyroidismRenal FailureChronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Laboratory measurement of intact parathyroid hormone (iPTH)

    6 months

Secondary Outcomes (1)

  • Laboratory measurement of serum bone markers

    6 months

Interventions

Hectorol (doxercalciferol capsules), 0.5mcgDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

AKDHC Medical Research Services

Phoenix, Arizona, 85012, United States

Location

UCLA Diabetes Reseach Center

Alhambra, California, United States

Location

Apex Research of Riverside

Riverside, California, 92501, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Discovery Medical Research Group

Ocala, Florida, 34471, United States

Location

Nephrology Associates

Palm Beach Gardens, Florida, 33410, United States

Location

Georgia Kidney Associates, Inc.

Marietta, Georgia, 30060, United States

Location

Michigan Kidney Consultants, P.C.

Pontiac, Michigan, 48341, United States

Location

Twin Cities Clinical Research

Brooklyn Center, Minnesota, 55430, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Wake Nephrology Associates, PA

Raleigh, North Carolina, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Location

Altru Health System Research Center

Grand Forks, North Dakota, 58201, United States

Location

DaVita Lewiston Dialysis Center

Lewiston, Pennsylvania, 17044, United States

Location

Temple University

Philadelphia, Pennsylvania, United States

Location

Virginia Commonwealth University

Richmond, Virginia, United States

Location

Instituto Renal del Este

Caguas, 00725, Puerto Rico

Location

Jose Cangiano, MD

San Juan, 00918, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryRenal InsufficiencyRenal Insufficiency, Chronic

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

July 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

US(17)PR(2)