Chronic Kidney Disease (CKD)MADRADNCT01415570
Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD)
An observational study of Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD), run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease (CKD), End-Stage Renal Disease (ESRD)
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (18-85 yrs) patients, hemodialysis (HD) > 4 weeks
Who may be able to join
- Adult (18-85 yrs) patients
- HD > 4 weeks
Who cannot join
- Terminal disease with life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harold Simmons Center for Kidney Disease Research & Epidemiology
Torrance, California, 90502
Claudia Luna, 310-222-2346, cluna@labiomed.org
About this study
Official title: Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study
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.
Read the detailed description
- SPECIFIC AIMS \& HYPOTHESES I.1.HYPOTHESES: Despite higher burden of chronic kidney disease (CKD) in minorities, they have greater survival compared to non-Hispanic Whites with CKD. The investigators hypothesize that survival advantages of minority CKD patients (pts) result from biologically plausible mechanisms related to differences in nutritional status \& diet (main hypothesis) or differences in bone-\&-minerals and/or psychosocial \& coping status (2 alternative hypotheses). Differences in these conditions may lead to different degrees of protein-energy wasting, inflammation, oxidative stress, \& platelet activation, leading to thrombo-embolic \& cardiovascular (CV) events. Discovering the biology of CKD racial survival disparities may lead to improving outcomes in both CKD and others chronic diseases.
During this 5-year study the principal investigator (Dr. Kalantar-Zadeh) will also help a number of early-career investigators to design and develop additional studies including research in minority populations with chronic diseases using data and resources of this study.
- Keywords
- Protein-energy wasting (PEW), racial disparities, hemodialysis, survival paradoxes, Stage 5
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hemodialysis Patients | Adult hemodialysis patients | |
| Chronic hemodialysis patients | Adult hemodialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 5-years (60 months)
Secondary outcomes (1)
Quality of life
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Davita Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kamyar Kalantar-Zadeh, MD, MPH, PhD, Principal investigator, LABioMed at Harbor-UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415570
- Sponsor's protocol ID
- 14100
- Other IDs
- K24DK091419
- Acronym
- MADRAD
- Status last verified
- May 2015
- First submitted
- 10 Aug 2011
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Noori N, Kovesdy CP, Dukkipati R, Feroze U, Molnar MZ, Bross R, Nissenson AR, Kopple JD, Norris KC, Kalantar-Zadeh K. Racial and ethnic differences in mortality of hemodialysis patients: role of dietary and nutritional status and inflammation. Am J Nephrol. 2011;33(2):157-67. doi: 10.1159/000323972. Epub 2011 Feb 4.
PubMed 21293117Feroze U, Noori N, Kovesdy CP, Molnar MZ, Martin DJ, Reina-Patton A, Benner D, Bross R, Norris KC, Kopple JD, Kalantar-Zadeh K. Quality-of-life and mortality in hemodialysis patients: roles of race and nutritional status. Clin J Am Soc Nephrol. 2011 May;6(5):1100-11. doi: 10.2215/CJN.07690910. Epub 2011 Apr 28.
PubMed 21527646Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Noori N, Murali SB, Block T, Norris J, Kopple JD, Block G. Design and development of a dialysis food frequency questionnaire. J Ren Nutr. 2011 May;21(3):257-62. doi: 10.1053/j.jrn.2010.05.013. Epub 2010 Sep 15.
PubMed 20833073Bross R, Noori N, Kovesdy CP, Murali SB, Benner D, Block G, Kopple JD, Kalantar-Zadeh K. Dietary assessment of individuals with chronic kidney disease. Semin Dial. 2010 Jul-Aug;23(4):359-64. doi: 10.1111/j.1525-139X.2010.00743.x. Epub 2010 Jul 29.
PubMed 20673254Bross R, Chandramohan G, Kovesdy CP, Oreopoulos A, Noori N, Golden S, Benner D, Kopple JD, Kalantar-Zadeh K. Comparing body composition assessment tests in long-term hemodialysis patients. Am J Kidney Dis. 2010 May;55(5):885-96. doi: 10.1053/j.ajkd.2009.12.031. Epub 2010 Mar 25.
PubMed 20346558Kalantar-Zadeh K, Kovesdy CP, Derose SF, Horwich TB, Fonarow GC. Racial and survival paradoxes in chronic kidney disease. Nat Clin Pract Nephrol. 2007 Sep;3(9):493-506. doi: 10.1038/ncpneph0570.
PubMed 17717562Kalantar-Zadeh K, Golan E, Shohat T, Streja E, Norris KC, Kopple JD. Survival disparities within American and Israeli dialysis populations: learning from similarities and distinctions across race and ethnicity. Semin Dial. 2010 Nov-Dec;23(6):586-94. doi: 10.1111/j.1525-139X.2010.00795.x.
PubMed 21175833Streja E, Kovesdy CP, Molnar MZ, Norris KC, Greenland S, Nissenson AR, Kopple JD, Kalantar-Zadeh K. Role of nutritional status and inflammation in higher survival of African American and Hispanic hemodialysis patients. Am J Kidney Dis. 2011 Jun;57(6):883-93. doi: 10.1053/j.ajkd.2010.10.050. Epub 2011 Jan 15.
PubMed 21239093Molnar MZ, Streja E, Kovesdy CP, Budoff MJ, Nissenson AR, Krishnan M, Anker SD, Norris KC, Fonarow GC, Kalantar-Zadeh K. High platelet count as a link between renal cachexia and cardiovascular mortality in end-stage renal disease patients. Am J Clin Nutr. 2011 Sep;94(3):945-54. doi: 10.3945/ajcn.111.014639. Epub 2011 Aug 3.
PubMed 21813809Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
PubMed 28324018
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study
- ClinicalTrials.gov ID
- NCT01415570
- Acronym / sponsor ID
- MADRAD / 14100
- Keywords
- Protein-energy wasting (PEW), racial disparities, hemodialysis, survival paradoxes, Stage 5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Davita Clinical Research
- Study start
- Aug 2011
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- SPECIFIC AIMS \& HYPOTHESES I.1.HYPOTHESES: Despite higher burden of chronic kidney disease (CKD) in minorities, they have greater survival compared to non-Hispanic Whites with CKD. The investigators hypothesize that survival advantages of minority CKD patients (pts) result from biologically plausible mechanisms related to differences in nutritional status \& diet (main hypothesis) or differences in bone-\&-minerals and/or psychosocial \& coping status (2 alternative hypotheses). Differences in these conditions may lead to different degrees of protein-energy wasting, inflammation, oxidative stress, \& platelet activation, leading to thrombo-embolic \& cardiovascular (CV) events. Discovering the biology of CKD racial survival disparities may lead to improving outcomes in both CKD and others chronic diseases.
During this 5-year study the principal investigator (Dr. Kalantar-Zadeh) will also help a number of early-career investigators to design and develop additional studies including research in minority populations with chronic diseases using data and resources of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Hemodialysis Patients | – | –Adult hemodialysis patients |
| Chronic hemodialysis patients | – | –Adult hemodialysis patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (18-85 yrs) patients, hemodialysis (HD) > 4 weeks
Key inclusion criteria (2 listed)
- Adult (18-85 yrs) patients
- HD > 4 weeks
Key exclusion criteria (1 listed)
- Terminal disease with life expectancy < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 5-years (60 months)
1 secondary outcome
Quality of life
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Background: PubMed 21293117Noori N, Kovesdy CP, Dukkipati R, Feroze U, Molnar MZ, Bross R, Nissenson AR, Kopple JD, Norris KC, Kalantar-Zadeh K. Racial and ethnic differences in mortality of hemodialysis patients: role of dietary and nutritional status and inflammation. Am J Nephrol. 2011;33(2):157-67. doi: 10.1159/000323972. Epub 2011 Feb 4.
- Background: PubMed 21527646Feroze U, Noori N, Kovesdy CP, Molnar MZ, Martin DJ, Reina-Patton A, Benner D, Bross R, Norris KC, Kopple JD, Kalantar-Zadeh K. Quality-of-life and mortality in hemodialysis patients: roles of race and nutritional status. Clin J Am Soc Nephrol. 2011 May;6(5):1100-11. doi: 10.2215/CJN.07690910. Epub 2011 Apr 28.
- Background: PubMed 20833073Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Noori N, Murali SB, Block T, Norris J, Kopple JD, Block G. Design and development of a dialysis food frequency questionnaire. J Ren Nutr. 2011 May;21(3):257-62. doi: 10.1053/j.jrn.2010.05.013. Epub 2010 Sep 15.
- Background: PubMed 20673254Bross R, Noori N, Kovesdy CP, Murali SB, Benner D, Block G, Kopple JD, Kalantar-Zadeh K. Dietary assessment of individuals with chronic kidney disease. Semin Dial. 2010 Jul-Aug;23(4):359-64. doi: 10.1111/j.1525-139X.2010.00743.x. Epub 2010 Jul 29.
- Background: PubMed 20346558Bross R, Chandramohan G, Kovesdy CP, Oreopoulos A, Noori N, Golden S, Benner D, Kopple JD, Kalantar-Zadeh K. Comparing body composition assessment tests in long-term hemodialysis patients. Am J Kidney Dis. 2010 May;55(5):885-96. doi: 10.1053/j.ajkd.2009.12.031. Epub 2010 Mar 25.
- Background: PubMed 17717562Kalantar-Zadeh K, Kovesdy CP, Derose SF, Horwich TB, Fonarow GC. Racial and survival paradoxes in chronic kidney disease. Nat Clin Pract Nephrol. 2007 Sep;3(9):493-506. doi: 10.1038/ncpneph0570.
- Background: PubMed 21175833Kalantar-Zadeh K, Golan E, Shohat T, Streja E, Norris KC, Kopple JD. Survival disparities within American and Israeli dialysis populations: learning from similarities and distinctions across race and ethnicity. Semin Dial. 2010 Nov-Dec;23(6):586-94. doi: 10.1111/j.1525-139X.2010.00795.x.
- Background: PubMed 21239093Streja E, Kovesdy CP, Molnar MZ, Norris KC, Greenland S, Nissenson AR, Kopple JD, Kalantar-Zadeh K. Role of nutritional status and inflammation in higher survival of African American and Hispanic hemodialysis patients. Am J Kidney Dis. 2011 Jun;57(6):883-93. doi: 10.1053/j.ajkd.2010.10.050. Epub 2011 Jan 15.
- Background: PubMed 21813809Molnar MZ, Streja E, Kovesdy CP, Budoff MJ, Nissenson AR, Krishnan M, Anker SD, Norris KC, Fonarow GC, Kalantar-Zadeh K. High platelet count as a link between renal cachexia and cardiovascular mortality in end-stage renal disease patients. Am J Clin Nutr. 2011 Sep;94(3):945-54. doi: 10.3945/ajcn.111.014639. Epub 2011 Aug 3.
- Derived from this study: PubMed 28324018Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamyar Kalantar-Zadeh, MD, MPH, PhD principal investigator
LABioMed at Harbor-UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD), run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caludia Luna (310-222-2346, cluna@labiomed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 5-years (60 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415570, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.