NCT02023528

Brief Summary

Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of dialysis patients is \~ 23% compared to \<0.1% in the United States general population. Even kidney transplant recipients have a substantially higher mortality (\~7%) compared to the general population. Consequently, the life-expectancy of dialysis and transplant populations is much lower than that of the general population. Cardiovascular events are the leading cause of death in dialysis patients and malnutrition is also a strong risk factor for death. The current proposal is to develop a prospective registry of incident dialysis patients at the University of Utah dialysis program to examine cardiovascular and nutritional factors in dialysis patients. This registry will include clinical and administrative data. In addition, blood samples will be stored for future analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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, 2008

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

7.9 years

First QC Date

December 23, 2013

Last Update Submit

August 9, 2016

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Demographics, co-morbid conditions and characteristics of dialysis patients

    The objective is to develop a registry of incident dialysis patients at the University of Utah dialysis program

    baseline

Eligibility Criteria

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

New patients starting on dialysis at the University of Utah care dialysis program.

You may qualify if:

  • Must be above the age of 18.
  • Consenting to participate in the registry.

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

US(1)