HyperparathyroidismPhase 2NCT00744302
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
A Phase 2 study testing physiological (1.25 mmol/L ) calcium dialysate in people with Hyperparathyroidism and Hypercalcemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Hyperparathyroidism, Hypercalcemia
- What is being tested?
- physiological (1.25 mmol/L ) calcium dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Apr 2006to Dec 2009
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willingness to sign an informed consent
- Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) > 150 pg/mL, hypercalcemia defined as serum Ca > 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2
Who cannot join
- Inability or unwillingness to sign the informed consent
- Cardiac arrhythmia
- Serious renal osteopathy
- Oral active vitamin D and/or calcium carbonate intolerance
- Poor compliance or unwillingness to meet the scheme demands raised by the investigators
- Patients who had undergone percutaneous ethanol injection therapy or parathyroidectomy for secondary hyperparathyroidism
- Patients who had previously been treated and/or were being treated with glucocorticoid, which affects bone metabolism.
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.
There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.
Read the detailed description
All patients recruited from these centers who met the inclusion criteria were randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.
Calcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite, calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary restriction when serum phosphate level could not get a good control (serum P level≥1.78 mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be administered for 1~2 weeks in patients with hypercalcaemia during the observation. At the time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium acetate were not available in our country.
- Conditions
- Hyperparathyroidism, Hypercalcemia
- Being tested
- physiological (1.25 mmol/L ) calcium dialysate
- Keywords
- Dialysate calcium, Mineral metabolism, Parathyroid hormone, Calcification, Cardiovascular disease, Haemodialysis
- Medical subject headings
- Hyperparathyroidism, Hypercalcemia, Calcinosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological (1.25 mmol/L ) calcium dialysateDrug
Using the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
| Study group | Role | What they receive |
|---|---|---|
| PCD | Experimental | Physiological calcium (1.25 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents. Receives: Drug: physiological (1.25 mmol/L ) calcium dialysate |
| NCD | Active comparator | Normal calcium (1.5 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents. Receives: Drug: physiological (1.25 mmol/L ) calcium dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of mineral metabolism and remission of secondary hyperparathyroidism
Measured: 2006-2009
Secondary outcomes (1)
Improvement of cardiovascular calcification and decrease of clinical cardiovascular events
Measured: 2006-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startApr 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, MD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen UniversityTanqi Luo, MD, Principal investigator, Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen UniversityQiong Luo, MD, Principal investigator, Department of Nephrology, Shen Zhen Affiliated Hospital of Peking UniversityYaozhong Kong, MD, Principal investigator, Department of Nephrology, the 1st People's Hospital Fo Shan CityWei Shi, MD, Principal investigator, Department of nephrology, People's Hospital of Guangdong ProvinceHaitang Hu, MD, Principal investigator, Department of Nephrology, People's Hospital Shun De CityZaiseng Zhou, MD, Principal investigator, Department of Nephrology, People's Hospital of Zhongshan City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744302
- Sponsor's protocol ID
- SYSU-PRGHD-001
- Status last verified
- May 2015
- First submitted
- 28 Aug 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
- ClinicalTrials.gov ID
- NCT00744302
- Acronym / sponsor ID
- SYSU-PRGHD-001
- Conditions
- Hyperparathyroidism, Hypercalcemia
- Keywords
- Dialysate calcium, Mineral metabolism, Parathyroid hormone, Calcification, Cardiovascular disease, Haemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Aug 2008 (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.
A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.
There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.
Detailed description
All patients recruited from these centers who met the inclusion criteria were randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.
Calcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite, calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary restriction when serum phosphate level could not get a good control (serum P level≥1.78 mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be administered for 1~2 weeks in patients with hypercalcaemia during the observation. At the time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium acetate were not available in our country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCD | Experimental | Drug: physiological (1.25 mmol/L ) calcium dialysatePhysiological calcium (1.25 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents. |
| NCD | Active comparator | Drug: physiological (1.25 mmol/L ) calcium dialysateNormal calcium (1.5 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to sign an informed consent
- Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) > 150 pg/mL, hypercalcemia defined as serum Ca > 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2
Key exclusion criteria (7 listed)
- Inability or unwillingness to sign the informed consent
- Cardiac arrhythmia
- Serious renal osteopathy
- Oral active vitamin D and/or calcium carbonate intolerance
- Poor compliance or unwillingness to meet the scheme demands raised by the investigators
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 |
|---|---|---|
| physiological (1.25 mmol/L ) calcium dialysateUsing the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session | Drug | NCD, PCD |
Primary outcome
Improvement of mineral metabolism and remission of secondary hyperparathyroidism
Time frame: 2006-2009
1 secondary outcome
Improvement of cardiovascular calcification and decrease of clinical cardiovascular events
Time frame: 2006-2009
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 22 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.
Xueqing Yu, MD principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Tanqi Luo, MD principal investigator
Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Qiong Luo, MD principal investigator
Department of Nephrology, Shen Zhen Affiliated Hospital of Peking University
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 physiological (1.25 mmol/L ) calcium dialysate in people with Hyperparathyroidism and Hypercalcemia, run by Sun Yat-sen University at 1 site in China.
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 7 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 22 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 1 site in China. 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?
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?
Improvement of mineral metabolism and remission of secondary hyperparathyroidism (time frame: 2006-2009). 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 22 May 2015.