Secondary HyperparathyroidismPhase 4NCT00123461
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
A Phase 4 study testing Hectorol (doxercalciferol capsules), 0.5mcg in people with Secondary Hyperparathyroidism and Renal Failure, run by Genzyme, a Sanofi Company at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
- What is being tested?
- Hectorol (doxercalciferol capsules), 0.5mcg
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jul 2005to Oct 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States17 sites
UCLA Diabetes Reseach Center
Alhambra, California
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Altru Health System Research Center
Grand Forks, North Dakota, 58201
DaVita Lewiston Dialysis Center
Lewiston, Pennsylvania, 17044
Georgia Kidney Associates, Inc.
Marietta, Georgia, 30060
Discovery Medical Research Group
Ocala, Florida, 34471
Nephrology Associates
Palm Beach Gardens, Florida, 33410
Temple University
Philadelphia, Pennsylvania
AKDHC Medical Research Services
Phoenix, Arizona, 85012
Michigan Kidney Consultants, P.C.
Pontiac, Michigan, 48341
Wake Nephrology Associates, PA
Raleigh, North Carolina
Virginia Commonwealth University
Richmond, Virginia
Apex Research of Riverside
Riverside, California, 92501
University of Rochester Medical Center
Rochester, New York, 14642
Montefiore Medical Center
The Bronx, New York
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Wake Forest University School of Medicine
Winston-Salem, North Carolina
Puerto Rico2 sites
Instituto Renal del Este
Caguas, 00725
Jose Cangiano, MD
San Juan, 00918
About this study
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).
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.
- Being tested
- Hectorol (doxercalciferol capsules), 0.5mcg
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hectorol (doxercalciferol capsules), 0.5mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory measurement of intact parathyroid hormone (iPTH)
Measured: 6 months
Secondary outcomes (1)
Laboratory measurement of serum bone markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123461
- Sponsor's protocol ID
- BCI-CH-151
- Status last verified
- May 2015
- First submitted
- 21 Jul 2005
- Last updated
- 5 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00123461
- Acronym / sponsor ID
- BCI-CH-151
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hectorol (doxercalciferol capsules), 0.5mcg | Drug | – |
Primary outcome
Laboratory measurement of intact parathyroid hormone (iPTH)
Time frame: 6 months
1 secondary outcome
Laboratory measurement of serum bone markers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hectorol (doxercalciferol capsules), 0.5mcg in people with Secondary Hyperparathyroidism and Renal Failure, run by Genzyme, a Sanofi Company at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory measurement of intact parathyroid hormone (iPTH) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.