NCT00793806

Brief Summary

The common causes of mortality are late stages of chronic kidney disease, cardiovascular disease and infections, are associated with abnormalities of the immune system, an underlying state of chronic inflammation and oxidative stress. These processes have not been carefully described in the chronic kidney disease population. The researcher can use Diffuse Optical Spectroscopy to determine the immune system in individuals with chronic kidney disease and describe the association with chronic inflammation and oxidative stress in that population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

August 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

3.6 years

First QC Date

November 14, 2008

Last Update Submit

October 19, 2022

Conditions

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Medical Tool

    Diffuse Optical Spectroscopy measure blood values changes during the hemodialysis treatment.

    4 weeks

Study Arms (1)

Medical Tool

Diffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease

Device: Diffuse Optical Spectroscopy

Interventions

Diffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease

Also known as: Diffuse Optical Spectroscopy measurements
Medical Tool

Eligibility Criteria

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

primary care clinic

You may qualify if:

  • years and older with chronic kidney disease undergoing hemodialysis have been treated with hemodialysis for at least 3 months
  • years and older for control

You may not qualify if:

  • acute kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

University of California Medical Center: Dialysis Unit

Orange, California, 92868, United States

Location

UCIMC Dialysis center

Orange, California, 92869, United States

Location

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

  • Madeleine Pahl, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Madeleine Pahl, M.D., Associate Professor of Medicine and Director of the Renal Clinic

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 19, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations