Secondary HyperparathyroidismPhase 4NCT01115543
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
A Phase 4 study testing alfacalcidol and calcitriol in people with Secondary Hyperparathyroidism and End Stage Renal Disease, run by Mahidol University at 1 site in Thailand.
Trial summary
This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, End Stage Renal Disease
- What is being tested?
- alfacalcidol and calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2008to Aug 2009
- 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
- Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels > 300 pg/mL)
Who cannot join
- (1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week and twice a week hemodialysis] (4) corrected serum calcium >10.2 mg/dL or serum phosphate >6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing Pulse Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients
This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.
Read the detailed description
Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.
- Being tested
- alfacalcidol and calcitriol
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfacalcidol and calcitriolDrug
The initial dose of alfacalcidol was twice that of calcitriol.Both were adjusted to control intact PTH within the ranges of 150-300 pg/ml.
| Study group | Role | What they receive |
|---|---|---|
| calcitriol | Active comparator | The subjects were randomized to receive calcitriol in a dose-escalating fashion for up to 24 weeks. Receives: Drug: alfacalcidol and calcitriol |
| alfacalcidol | Experimental | Not described Receives: Drug: alfacalcidol and calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of intact parathyroid hormone levels
Measured: 48 weeks
Secondary outcomes (1)
hypercalcemia and hyperphosphatemia
proportion of the patients who achieved a target PTH, changes in plasma calcium and phosphorus, the proportion of the patients who had hypercalcemia (plasma corrected calcium > 10.8 mg/dl), hyperphosphatemia (plasma phosphorus > 6.0 mg/dl) and calcium-phosphorus products > 55 mg2/dl2 between groups.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionAug 2009
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115543
- Sponsor's protocol ID
- 358/2551
- Status last verified
- May 2010
- First submitted
- 1 May 2010
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Pulse Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01115543
- Acronym / sponsor ID
- 358/2551
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 May 2010 (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.
This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.
Detailed description
Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcitriol | Active comparator | Drug: alfacalcidol and calcitriolThe subjects were randomized to receive calcitriol in a dose-escalating fashion for up to 24 weeks. |
| alfacalcidol | Experimental | Drug: alfacalcidol and calcitriol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels > 300 pg/mL)
Key exclusion criteria (1 listed)
- (1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week and twice a week hemodialysis] (4) corrected serum calcium >10.2 mg/dL or serum phosphate >6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
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 |
|---|---|---|
| alfacalcidol and calcitriolThe initial dose of alfacalcidol was twice that of calcitriol.Both were adjusted to control intact PTH within the ranges of 150-300 pg/ml. | Drug | alfacalcidol, calcitriol |
Primary outcome
Reduction of intact parathyroid hormone levels
Time frame: 48 weeks
1 secondary outcome
hypercalcemia and hyperphosphatemia
Time frame: 48 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 4 May 2010.
Related trials for Secondary Hyperparathyroidism
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alfacalcidol and calcitriol in people with Secondary Hyperparathyroidism and End Stage Renal Disease, run by Mahidol University 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 1 inclusion and 1 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 4 May 2010. 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 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?
Reduction of intact parathyroid hormone levels (time frame: 48 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 4 May 2010.