NCT01781156

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 17, 2015

Status Verified

November 1, 2014

Enrollment Period

4.5 years

First QC Date

January 24, 2013

Last Update Submit

March 14, 2015

Conditions

Keywords

phosphorushemodialysiscardiac biomarkers

Outcome Measures

Primary Outcomes (1)

  • Reducing cardiac biomarkers in hemodialysis patients

    6 months

Secondary Outcomes (1)

  • Improving cardiac function

    1 year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will be selected from patients of nephrology department of Shanghai 10th people's hospital in Shanghai,China.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, 200072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ai Peng, Ph.D,M.D

    Shanghai 10th People's Hospital of Tongji University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of Nephrology, Shanghai 10th poeple's hospital

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 31, 2013

Study Start

August 1, 2012

Primary Completion

February 1, 2017

Study Completion

June 1, 2018

Last Updated

March 17, 2015

Record last verified: 2014-11

Locations