Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT01415570

Conditions

Chronic Kidney Disease (CKD)

End-Stage Renal Disease (ESRD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to suffer from chronic kidney disease and need dialysis treatment for life, when compared to the non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle and fat wasting are even more likely to die. Interestingly, among dialysis patients, minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the non-Hispanic Whites. If the investigators can discover the reasons for these so-called "racial survival disparities" of dialysis patients, the investigators may be able to improve survival for all dialysis patients and maybe even for many other people who suffer from other chronic diseases. During this 5 year study the investigators would like to test if a different nutrition and diet can explain better survival of minority dialysis patients. The investigators will also test if in additional to nutrition there are 2 other reasons for better survival of minority dialysis patients, namely differences in bone and minerals and differences in social and psychological and mental health. The investigators plan to study 450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic Whites and 10% Asians. Every 6 months the investigators will examine their nutritional conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75 new subjects to replace those who left our study as a result of kidney transplantation, death or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis patients over 5 years. Clinical events such as hospital admissions and survival will be followed. Blood samples will be obtained every 6 months for measurements of hormones and "biomarkers", and the remainder of the blood will be stored in freezers for future measurements. The investigators plan to design and develop race and ethnicity specific nutritional risk scores and food questionnaires and will test some of these scores in larger national databases of hemodialysis patients. Almost a year after the study starts, the investigators also plan to do additional tests of body composition and dietary intake in a smaller group of these patients at the GCRC.

Conditions

Chronic Kidney Disease (CKD)

End-Stage Renal Disease (ESRD)

Study ID

NCT01415570

Start date

Aug, 2011

Status verified date

May, 2015

Completion date

Nov, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (18-85 yrs) patients
  • HD > 4 weeks

Exclusion Criteria:

  • Terminal disease with life expectancy < 6 months

Study Design

Enrollment

1050 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic Hemodialysis Patients

Adult hemodialysis patients

Chronic hemodialysis patients

Adult hemodialysis patients

Primary outcome measure

  • All-cause mortality [ Time Frame: 5-years (60 months) ]

Central Contacts and Locations

Central contacts

Locations

Harold Simmons Center for Kidney Disease Research & Epidemiology

Recruiting

Torrance, California, United States, 90502

Contacts

More Information

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Last update posted

May 21, 2015

Last verified

May, 2015

Keywords

  • Protein-energy wasting (PEW)
  • racial disparities
  • hemodialysis
  • survival paradoxes
  • Stage 5

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center on 2015-05-21.