End Stage Renal FailureNCT01781156
Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients
An observational study of End Stage Renal Failure, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(ESRD),however the majority of whom are in the absence of acute coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in those patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Failure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Jun 2018
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from patients of nephrology department of Shanghai 10th people's hospital in Shanghai,China.
Who may be able to join
- Time of receiving hemodialysis is more than 1 year;
- Hyperphosphatemia before hemodialysis;
- Never use any phosphorus binder in the past 6 months.
Who cannot join
- Receiving coronary artery stent implantation before;
- Having any cardiovascular disease in the past 6 months;
- Cannot tolerate the side effects of phosphorus binder;
- Dose not take medicine according to the prescription;
- inadequate dialysis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, 200072
Ai Peng, Ph.D,M.D, 86-021-66302524, pengai@hotmail.com
Shu Wang, M.D
About this study
Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(ESRD),however the majority of whom are in the absence of acute coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in hemodialysis patients for some time and observed the change of cardiac biomarkers of those patients.
Read the detailed description
Cardiovascular disease is one of the leading causes of morbidity and mortality in patient with chronic kidney disease(CKD), accounting for more than 50% of all deaths.When myocardial cells get injured, cardiac biomarkers will be released into the circulation. Elevated cardiac biomarkers have been observed in patients with various degrees of renal failure. However, the majority of those CKD patients are in the absence of acute coronary syndrome. So far, it is still unclear the mechanisms of the increased biomarkers in CKD patients. Meanwhile, hyperphosphatemia is one of the major features of CKD, particularly of end stage renal disease(ESRD). Lots of evidences have shown that high levels of serum phosphorus and an elevation of the serum calcium × phosphorus product can lead to cardiovascular calcifications and subsequent cardiovascular morbidity and mortality in patients with CKD.it is tempting to hypothesize that hyperphosphatemia may be responsible for the rise of cardiac biomarkers in CKD patients.So we use one phosphate binder to reduce phosphorus absorption in hemodialysis patients for one year and observe the change of cardiac biomarkers of those patients.
- Conditions
- End Stage Renal Failure
- Keywords
- phosphorus, hemodialysis, cardiac biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing cardiac biomarkers in hemodialysis patients
Measured: 6 months
Secondary outcomes (1)
Improving cardiac function
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 posted31 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal FailureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ai Peng, Ph.D,M.D, Principal investigator, Shanghai 10th People's Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781156
- Sponsor's protocol ID
- 2012RES-047
- Other IDs
- 81270136
- Status last verified
- Nov 2014
- First submitted
- 24 Jan 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01781156
- Acronym / sponsor ID
- 2012RES-047
- Conditions
- End Stage Renal Failure
- Keywords
- phosphorus, hemodialysis, cardiac biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 31 Jan 2013 (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.
Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(ESRD),however the majority of whom are in the absence of acute coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in hemodialysis patients for some time and observed the change of cardiac biomarkers of those patients.
Detailed description
Cardiovascular disease is one of the leading causes of morbidity and mortality in patient with chronic kidney disease(CKD), accounting for more than 50% of all deaths.When myocardial cells get injured, cardiac biomarkers will be released into the circulation. Elevated cardiac biomarkers have been observed in patients with various degrees of renal failure. However, the majority of those CKD patients are in the absence of acute coronary syndrome. So far, it is still unclear the mechanisms of the increased biomarkers in CKD patients. Meanwhile, hyperphosphatemia is one of the major features of CKD, particularly of end stage renal disease(ESRD). Lots of evidences have shown that high levels of serum phosphorus and an elevation of the serum calcium × phosphorus product can lead to cardiovascular calcifications and subsequent cardiovascular morbidity and mortality in patients with CKD.it is tempting to hypothesize that hyperphosphatemia may be responsible for the rise of cardiac biomarkers in CKD patients.So we use one phosphate binder to reduce phosphorus absorption in hemodialysis patients for one year and observe the change of cardiac biomarkers of those patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from patients of nephrology department of Shanghai 10th people's hospital in Shanghai,China.
Key inclusion criteria (3 listed)
- Time of receiving hemodialysis is more than 1 year;
- Hyperphosphatemia before hemodialysis;
- Never use any phosphorus binder in the past 6 months.
Key exclusion criteria (5 listed)
- Receiving coronary artery stent implantation before;
- Having any cardiovascular disease in the past 6 months;
- Cannot tolerate the side effects of phosphorus binder;
- Dose not take medicine according to the prescription;
- inadequate dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reducing cardiac biomarkers in hemodialysis patients
Time frame: 6 months
1 secondary outcome
Improving cardiac function
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 17 Mar 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.
Ai Peng, Ph.D,M.D principal investigator
Shanghai 10th People's Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure, run by Shanghai 10th People's Hospital 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 5 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 17 Mar 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 Ai Peng, Ph.D,M.D (86-021-66302524, pengai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing cardiac biomarkers in hemodialysis patients (time frame: 6 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 17 Mar 2015.