Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

NCT ID: NCT01781156

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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

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End Stage Renal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Time of receiving hemodialysis is more than 1 year;
* Hyperphosphatemia before hemodialysis;
* Never use any phosphorus binder in the past 6 months.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ai Peng

Director of the department of Nephrology, Shanghai 10th poeple's hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ai Peng, Ph.D,M.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital of Tongji University

Locations

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Shanghai 10th People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ai Peng, Ph.D,M.D

Role: CONTACT

86-021-66302524

Shu Wang, M.D

Role: CONTACT

86-021-66302527

Facility Contacts

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Ai Peng, Ph.D,M.D

Role: primary

86-021-66302524

Other Identifiers

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81270136

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012RES-047

Identifier Type: -

Identifier Source: org_study_id

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