Vascular CalcificationPhase 2NCT01364688
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
A Phase 2 study testing oral alfacalcidol and no drug in people with Vascular Calcification, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Calcification
- What is being tested?
- oral alfacalcidol and no drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 2
- 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
- Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
- PTH above the upper limit of normal
- serum calcium and phosphate below the upper limit of normal
Who cannot join
- changes in GFR>15% during the past 3 months
- receive elemental calcium>500 mg/day
- currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Phayathai, Bangkok, 10400
Sinee Disthabanchong, MD, +662011116, tesdb@mahidol.ac.th
About this study
Official title: Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.
Read the detailed description
Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.
- Conditions
- Vascular Calcification
- Being tested
- oral alfacalcidol, no drug
- Keywords
- coronary calcification, vascular calcification, active vitamin D, alfacalcidol
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral alfacalcidolDrug
Oral alfacalcidol 0.5 microgram per day
no drugDrug
no drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | oral alfacalcidol Receives: Drug: oral alfacalcidol |
| Control | No intervention | No drug Receives: Drug: no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Coronary Artery Calcification
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364688
- Sponsor's protocol ID
- 25-05-2011
- Status last verified
- May 2011
- First submitted
- 26 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01364688
- Acronym / sponsor ID
- 25-05-2011
- Conditions
- Vascular Calcification
- Keywords
- coronary calcification, vascular calcification, active vitamin D, alfacalcidol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Jun 2011 (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.
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.
Detailed description
Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: oral alfacalcidoloral alfacalcidol |
| Control | No intervention | Drug: no drugNo drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
- PTH above the upper limit of normal
- serum calcium and phosphate below the upper limit of normal
Key exclusion criteria (3 listed)
- changes in GFR>15% during the past 3 months
- receive elemental calcium>500 mg/day
- currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate
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 |
|---|---|---|
| oral alfacalcidolOral alfacalcidol 0.5 microgram per day | Drug | Treatment |
| no drugno drug | Drug | Control |
Primary outcome
Change in Coronary Artery Calcification
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral alfacalcidol and no drug in people with Vascular Calcification, run by Ramathibodi Hospital at 1 site in Thailand.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2011. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinee Disthabanchong, MD (+6622011116, tesdb@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Coronary Artery Calcification (time frame: 6 months and 12 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 2 Jun 2011.