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Trial record 33 of 51 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study) (AI-CRIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04185844
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-Phoenix Epidemiology and Clinical Research
Zuni Pueblo
Urban Albuquerque Area American Indians seen at First Nations Hospital
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:
Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.

Condition or disease
Diabetes Mellitus Chronic Kidney Diseases Heart Diseases Cardiovascular Diseases

Detailed Description:

Investigators will conduct a longitudinal study of a CKD cohort of Southwest AIs to identify unique risk factors for CKD and CVD progression and compare CKD and CVD event rates and risk factors between AI and the populations represented in CRIC. Investigators will establish a specimen bank to support future ancillary studies designed to identify and examine biomarkers associated with the progression of CKD in AIs.

At the Clinic Visit the following will occur:

  • weight is measured
  • blood pressure and heart rate are recorded
  • information about medical history and medication used recently
  • blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of metabolism, and several other heart and kidney tests
  • blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)
  • urine sample collection for kidney function testing
  • complete questionnaires about quality of life, diet, mood, thought processes and physical activity.

This visit takes about 1 to 2 hours. Participants will be contacted by telephone six months after the Baseline Visit to ask about recent medical events and medications.

Participants will be asked to return to the center for annual visits during which many but not all of the procedures described above will be conducted.

Additionally, participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Slope of the GFR [ Time Frame: 5 years ]
    Primary outcomes regarding Cardio vascular disease will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD.

Secondary Outcome Measures :
  1. Onset of End Stage Renal Disease [ Time Frame: 5 years ]
    The measure is reflected in decline of GFR levels

  2. Significant loss of renal function [ Time Frame: 5 years ]
    The measure is reflected in decline of GFR levels

  3. Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l/min/1.73 m2 decline in GFR from baseline, or onset of ESRD [ Time Frame: 5 years ]
    The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline

  4. Slope of change in proteinuria over time [ Time Frame: 5 years ]
    The changes in the levels of proteinuria overtime

Biospecimen Retention:   Samples With DNA
blood, urine serum, plasma, DNA, RNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
American Indians at 3 sites.

Inclusion Criteria:

  • Glomerular Filtration Rate (GFR): eGFR of =>61<80 and microalbuminuria > 30 or eGRF of =<60 (no microalbuminuria required).

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent
  2. life expectancy <3 years;
  3. institutionalized subjects;
  4. End stage renal disease or renal transplant;
  5. renal cancer;
  6. myeloma;
  7. immunosuppression;
  8. Polycystic kidney disease;
  9. participation in any clinical trial,
  10. current pregnancy
  11. current incarceration.
  12. Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04185844

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Contact: Vallabh Shah 505-272-9615

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United States, Arizona
NIDDK-Phoenix Epidemiology and Clinical Research Not yet recruiting
Phoenix, Arizona, United States, 85016
United States, New Mexico
First Nations Community Health Source Not yet recruiting
Albuquerque, New Mexico, United States, 87108
Zuni Health Initiative Center Not yet recruiting
Black Rock, New Mexico, United States, 87327
Sponsors and Collaborators
University of New Mexico
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-Phoenix Epidemiology and Clinical Research
Zuni Pueblo
Urban Albuquerque Area American Indians seen at First Nations Hospital
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Principal Investigator: Vallabh Shah University of New Mexico

Additional Information:
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Responsible Party: University of New Mexico Identifier: NCT04185844     History of Changes
Other Study ID Numbers: 19-159
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Urologic Diseases