Coronary Artery CalcificationNCT02498457
The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
A study testing low calcium dialysis in people with Coronary Artery Calcification, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Calcification
- What is being tested?
- low calcium dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Mar 2016
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH <500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
- Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
- Patients who signed informed consent documents at the time of enrollment in the study.
Who cannot join
- Patients whose heart or lung function are poor, or with unstable hemodynamics.
- Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
- Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Jie Hao, MD, 86-23-89012409, ghzxgckd@163.com
About this study
Official title: The First Affiliated Hospital of Chongqing Medical University
This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.
Read the detailed description
MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.
- Conditions
- Coronary Artery Calcification
- Being tested
- low calcium dialysis
- Keywords
- maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low calcium dialysisOther
patients in this group will receive low calcium dialysis for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| low calcium dialysis | Active comparator | patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L. Receives: Other: low calcium dialysis |
| Routine dialysis | Other | Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L. Receives: Other: low calcium dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in coronary artery calcification after 1 year's treatment
Measured: 1 year
Secondary outcomes (1)
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Hua Gan, Dr., Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498457
- Sponsor's protocol ID
- 1stChongqingMU snkxia1
- Status last verified
- Jul 2015
- First submitted
- 13 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT02498457
- Acronym / sponsor ID
- 1stChongqingMU snkxia1
- Conditions
- Coronary Artery Calcification
- Keywords
- maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 15 Jul 2015 (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 aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.
Detailed description
MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low calcium dialysis | Active comparator | Other: low calcium dialysispatients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L. |
| Routine dialysis | Other | Other: low calcium dialysisPatients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH <500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
- Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
- Patients who signed informed consent documents at the time of enrollment in the study.
Key exclusion criteria (3 listed)
- Patients whose heart or lung function are poor, or with unstable hemodynamics.
- Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
- Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.
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 |
|---|---|---|
| low calcium dialysispatients in this group will receive low calcium dialysis for 1 year. | Other | Routine dialysis, low calcium dialysis |
Primary outcome
Changes in coronary artery calcification after 1 year's treatment
Time frame: 1 year
1 secondary outcome
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
Hua Gan, Dr. study director
First Affiliated Hospital of Chongqing Medical 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 low calcium dialysis in people with Coronary Artery Calcification, run by First Affiliated Hospital of Chongqing Medical 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 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 15 Jul 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.
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 Yunfeng Xia, Dr. (86-23-89012256, xyf0920@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in coronary artery calcification after 1 year's treatment (time frame: 1 year). 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 15 Jul 2015.