Secondary HyperparathyroidismNCT00828347
Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
A study testing 1.0 μg/day Alfacalcidol and 0.25 μg/day Alfacalcidol in people with Secondary Hyperparathyroidism, run by Kumamoto University at 1 site in Japan.
Trial summary
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at… 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?
- 1.0 μg/day Alfacalcidol and 0.25 μg/day Alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of secondary hyperparathyroidism (iPTH >200 pg/mL to <500 pg/mL)
- Serum Ca < 11.0 mg/dL, and serum P < 7.0 mg/dL.
- At least one year of regular hemodialysis therapy
Who cannot join
- Patients with a history of hypersensitivity to any ingredient of maxacalcitol
- Patients who had received parathyroidectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.
Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to < 150 pg/mL.
Read the detailed description
Chronic kidney disease (CKD) causes various bone mineral disorders, which have recently been named CKD mineral and bone disorder (CKD-MBD). CKD-MBD presents a spectrum of skeletal abnormalities ranging from high bone turnover state such as osteitis fibrosa, which is seen with SHPT, to states of low bone turnover, which includes osteomalacia and adynamic bone disease. This disease not only increases the risk of cardiovascular disease and mortality, but also increases the risk of fracture. Therefore, it is important to correct the serum inorganic phosphorus (Pi), calcium (Ca) and parathyroid hormone (PTH) levels in dialysis patients, to achieve both appropriate bone turnover and to improve mortality.
The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that the target range of iPTH level for vitamin D therapy should be set at 150-300 pg/mL. In Japan, the mortality risk was significantly lower in the group of patients with iPTH levels < 120 pg/mL than in the standard group set at 180 pg/mL < iPTH < 360 pg/mL, and lowest in the group of patients with 60 pg/mL < iPTH < 120 pg/mL . Based on these findings, Japanese guideline recommend that the target range of iPTH should be set at 60-180 pg/mL .
The efficacies of various oral and intravenous vitamin D preparations for treating SHPT in hemodialysis patients have been reported. and oral or intravenous vitamin D pulse therapy has been clinically applied, especially for patients with severe SHPT.
Up to now, the effectiveness of an oral daily alfacalcidol on SHPT has been confirmed at the dose of 0.25-0.5 μg /day (average 0.364μg /day), 0.5 μg /day, and 1.0 μg /day. The effective dose of OCT has also been verified, and furthermore, it has also been reported that intravenous vitamin D was more effective than oral vitamin D for suppressing PTH secretion. Accordingly, at present intravenous vitamin D therapy is the standard treatment for SHPT, and there are established protocols with regard to dosage and administration. However, no protocols have been established for maintenance therapy using intravenous or oral vitamin D preparations after the control of iPTH target range has been achieved.
Therefore, the present study compared the efficacy of two maintenance therapy protocols for patients with SHPT who responded to initial OCT therapy, resulting in the control of iPTH to <150pg/mL. One was oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 μg/day (higher-dose group) and the other was at a dose of 0.25 μg/day (lower-dose group), both of which are clinically effective doses for HD patients with SHPT.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- 1.0 μg/day Alfacalcidol, 0.25 μg/day Alfacalcidol
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0 μg/day AlfacalcidolDrug
Also called One alpha
We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
0.25 μg/day AlfacalcidolDrug
Also called One alpha
We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1.0 μg/day Alfacalcidol | Other | Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months Receives: Drug: 1.0 μg/day Alfacalcidol |
| 0.25 μg/day Alfacalcidol | Other | Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months Receives: Drug: 0.25 μg/day Alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level
Measured: Participants were followed for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masataka Adachi, Kumamoto University
- Investigators
- Masataka Adachi, M.D., Ph.D., Principal investigator, Department nephrology Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828347
- Sponsor's protocol ID
- KumaNeph2
- Status last verified
- Dec 2015
- First submitted
- 22 Jan 2009
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00828347
- Acronym / sponsor ID
- KumaNeph2
- Conditions
- Secondary Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.
Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to < 150 pg/mL.
Detailed description
Chronic kidney disease (CKD) causes various bone mineral disorders, which have recently been named CKD mineral and bone disorder (CKD-MBD). CKD-MBD presents a spectrum of skeletal abnormalities ranging from high bone turnover state such as osteitis fibrosa, which is seen with SHPT, to states of low bone turnover, which includes osteomalacia and adynamic bone disease. This disease not only increases the risk of cardiovascular disease and mortality, but also increases the risk of fracture. Therefore, it is important to correct the serum inorganic phosphorus (Pi), calcium (Ca) and parathyroid hormone (PTH) levels in dialysis patients, to achieve both appropriate bone turnover and to improve mortality.
The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that the target range of iPTH level for vitamin D therapy should be set at 150-300 pg/mL. In Japan, the mortality risk was significantly lower in the group of patients with iPTH levels < 120 pg/mL than in the standard group set at 180 pg/mL < iPTH < 360 pg/mL, and lowest in the group of patients with 60 pg/mL < iPTH < 120 pg/mL . Based on these findings, Japanese guideline recommend that the target range of iPTH should be set at 60-180 pg/mL .
The efficacies of various oral and intravenous vitamin D preparations for treating SHPT in hemodialysis patients have been reported. and oral or intravenous vitamin D pulse therapy has been clinically applied, especially for patients with severe SHPT.
Up to now, the effectiveness of an oral daily alfacalcidol on SHPT has been confirmed at the dose of 0.25-0.5 μg /day (average 0.364μg /day), 0.5 μg /day, and 1.0 μg /day. The effective dose of OCT has also been verified, and furthermore, it has also been reported that intravenous vitamin D was more effective than oral vitamin D for suppressing PTH secretion. Accordingly, at present intravenous vitamin D therapy is the standard treatment for SHPT, and there are established protocols with regard to dosage and administration. However, no protocols have been established for maintenance therapy using intravenous or oral vitamin D preparations after the control of iPTH target range has been achieved.
Therefore, the present study compared the efficacy of two maintenance therapy protocols for patients with SHPT who responded to initial OCT therapy, resulting in the control of iPTH to <150pg/mL. One was oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 μg/day (higher-dose group) and the other was at a dose of 0.25 μg/day (lower-dose group), both of which are clinically effective doses for HD patients with SHPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.0 μg/day Alfacalcidol | Other | Drug: 1.0 μg/day AlfacalcidolAlfacalcidol 1.0 μg capsule by mouth, every day for 6 months |
| 0.25 μg/day Alfacalcidol | Other | Drug: 0.25 μg/day AlfacalcidolAlfacalcidol 0.25 μg capsule by mouth, every day for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of secondary hyperparathyroidism (iPTH >200 pg/mL to <500 pg/mL)
- Serum Ca < 11.0 mg/dL, and serum P < 7.0 mg/dL.
- At least one year of regular hemodialysis therapy
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to any ingredient of maxacalcitol
- Patients who had received parathyroidectomy
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 |
|---|---|---|
| 1.0 μg/day AlfacalcidolAlso: One alphaWe compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. | Drug | 1.0 μg/day Alfacalcidol |
| 0.25 μg/day AlfacalcidolAlso: One alphaWe compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. | Drug | 0.25 μg/day Alfacalcidol |
Primary outcome
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level
Time frame: Participants were followed for 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Secondary Hyperparathyroidism
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
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.
Masataka Adachi, M.D., Ph.D. principal investigator
Department nephrology Kumamoto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.0 μg/day Alfacalcidol and 0.25 μg/day Alfacalcidol in people with Secondary Hyperparathyroidism, run by Kumamoto University at 1 site in Japan.
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 2 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level (time frame: Participants were followed for 24 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 25 Jan 2016.