Clinical trial NCT04185844: American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Official title: American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Chronic Kidney Diseases
Heart Diseases
Cardiovascular Diseases
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: American Indians at 3 sites.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Slope of the GFR
timeFrame: 5 years
Secondary outcomes:
measure: Onset of End Stage Renal Disease
timeFrame: 5 years
measure: Significant loss of renal function
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Slope of change in proteinuria over time
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NIDDK-Phoenix Epidemiology and Clinical Research
state: Arizona
city: Albuquerque
country: United States
facility: First Nations Community Health Source
state: New Mexico
city: Black Rock
country: United States
facility: Zuni Health Initiative Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Mark L Unruh, MD
role: PRINCIPAL_INVESTIGATOR
References: