NCT03391128

Brief Summary

This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2005

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

December 28, 2017

Last Update Submit

January 4, 2018

Conditions

Cardiovascular EventsCardiac Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

    Cardiac deaths, non-fatal acute myocardial infarction, obstructive coronary artery disease needing intervention, vasospastic angina identified by angiography, heart failure needing hospitalization, bradycardia needing pacemaker implantation, dissecting aortic aneurysm, cardiac valvular disease needing valve replacement, peripheral artery disease needing bypass surgery or leg amputation.

    January 1, 2005 to January 31, 2011

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Of 302 patients who met the inclusion criteria, 58 patients were excluded based on the exclusion criteria. Consequently, 244 patients (126 men and 118 women; mean age, 64 ± 11 years; dialysis duration, 11.5 ± 7.8 years) were enrolled in the study.

You may qualify if:

  • End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005

You may not qualify if:

  • Histories of coronary events and/or interventions
  • Congestive heart failure of New York Heart Association grades III to IV
  • Moderate or worse valvular heart disease
  • Permanent pacemaker implantation
  • Idiopathic cardiomyopathy
  • Chronic obstructive pulmonary disease
  • Malignancy
  • Acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toujinkai Hospital

Kyoto, 612-8026, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for measurement of serum P3NP concentration.

Study Officials

  • Masato Nishimura, MD

    Tojinkai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular division

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 5, 2018

Study Start

January 1, 2005

Primary Completion

January 31, 2005

Study Completion

January 31, 2005

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)