Secondary HyperparathyroidismPhase 4NCT00418600
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
A Phase 4 study testing Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol® and doxercalciferol capsules, Hectorol® capsules in people with Secondary Hyperparathyroidism, run by Genzyme, a Sanofi Company at 8 sites in United States.
Trial summary
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol® and doxercalciferol capsules, Hectorol® capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2006to Aug 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
- The subject must be receiving hemodialysis three times per week for a minimum of six months.
- The subject must have been receiving Hectorol Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
Who cannot join
- In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
- Current use of aluminum or magnesium based binders.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Atlanta, Georgia
Study site
Cincinnati, Ohio
Study site
Downey, California
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Pittsburgh, Pennsylvania
Study site
Spokane, Washington
Study site
Tarzana, California
About this study
Official title: A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules
- Keywords
- Secondary Hyperparathyroidism, Hectorol® (doxercalciferol capsules), Hectorol® (doxercalciferol injection)
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hectorol® (doxercalciferol capsules)Drug
Hectorol capsules at 1.0 times current injection dose
doxercalciferol capsules, Hectorol®Drug
Hectorol capsules at 1.5 times current injection dose
doxercalciferol capsules, Hectorol® capsulesDrug
Hectorol capsules at 2.0 times current injection dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Hectorol capsules at 1.0 times current injection dose Receives: Drug: Hectorol® (doxercalciferol capsules) |
| 2 | Other | Hectorol capsules at 1.5 times current injection dose Receives: Drug: doxercalciferol capsules, Hectorol® |
| 3 | Other | Hectorol capsules at 2.0 times current injection dose Receives: Drug: doxercalciferol capsules, Hectorol® capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Conversion
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionAug 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
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT00418600
- Sponsor's protocol ID
- HECT00406
- Status last verified
- Mar 2015
- First submitted
- 3 Jan 2007
- Last updated
- 19 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis
- ClinicalTrials.gov ID
- NCT00418600
- Acronym / sponsor ID
- HECT00406
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary Hyperparathyroidism, Hectorol® (doxercalciferol capsules), Hectorol® (doxercalciferol injection)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 5 Jan 2007 (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.
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Hectorol® (doxercalciferol capsules)Hectorol capsules at 1.0 times current injection dose |
| 2 | Other | Drug: doxercalciferol capsules, Hectorol®Hectorol capsules at 1.5 times current injection dose |
| 3 | Other | Drug: doxercalciferol capsules, Hectorol® capsulesHectorol capsules at 2.0 times current injection dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject must be receiving hemodialysis three times per week for a minimum of six months.
- The subject must have been receiving Hectorol Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
Key exclusion criteria (5 listed)
- In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
- Current use of aluminum or magnesium based binders.
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)Hectorol capsules at 1.0 times current injection dose | Drug | 1 |
| doxercalciferol capsules, Hectorol®Hectorol capsules at 1.5 times current injection dose | Drug | 2 |
| doxercalciferol capsules, Hectorol® capsulesHectorol capsules at 2.0 times current injection dose | Drug | 3 |
Primary outcome
Dose Conversion
Time frame: 5 weeks
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 19 Mar 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol® and doxercalciferol capsules, Hectorol® capsules in people with Secondary Hyperparathyroidism, run by Genzyme, a Sanofi Company at 8 sites in United States.
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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Dose Conversion (time frame: 5 weeks). 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 19 Mar 2015.