Actively Recruiting
American Indian Chronic Renal Insufficiency Cohort Study to Identify Risk Factors for CKD and Cardiovascular Disease Progression
Led by University of New Mexico · Updated on 2026-05-20
500
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating chronic kidney disease (CKD) and cardiovascular disease (CVD) in American Indians (AIs) in the Southwestern US to understand unique risk factors and disease progression in this population. This observational study builds upon the parent CRIC study and aims to improve knowledge of CKD and CVD burden among AIs by using updated protocols and measurements. Participants will undergo a baseline clinic visit where weight, blood pressure, heart rate, medical history, and medication use are recorded. Blood and urine samples are collected to assess kidney and heart function. The Ankle Brachial Index (ABI) is measured, and participants complete questionnaires on quality of life, diet, mood, thinking, and physical activity. Follow-up telephone contact occurs six months later to check on medical events and medications. Annual visits will repeat many of these assessments. Additionally, participants may join one of two substudies involving remote data collection to study kidney function and cardiovascular risk over time. The main measure of interest is the slope of kidney function decline over five years. Secondary outcomes include onset of end stage renal disease, significant loss of renal function, and changes in protein levels in urine. Participants are monitored regularly through clinic visits and phone calls for up to five years. A specimen bank will be established to support future research on biomarkers related to CKD progression in AIs. The total study duration spans several years, with ongoing evaluations to track kidney and heart health.
CONDITIONS
Brief Title
American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 80 years
- eGFR between 61 and 80 with microalbuminuria over 30, or eGFR of 60 or less
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Life expectancy less than 3 years
- Institutionalized individuals
- End stage renal disease or renal transplant
- Renal cancer
- Myeloma
- Immunosuppression
- Polycystic kidney disease
- Currently participating in any clinical trial
- Current pregnancy
- Current incarceration
- Unable or unlikely to participate in required study procedures as assessed by study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants attend a baseline clinic visit where weight, blood pressure, heart rate, medical history, and medication use are assessed. Blood and urine samples are collected for kidney and heart function tests and questionnaires about quality of life, diet, mood, thought processes, and physical activity are completed. Participants are contacted by phone six months after the baseline visit to report recent medical events and medications.
1 baseline visit (in-person), 1 phone call at 6 months, and annual in-person visits
Trial Site Locations
Total: 3 locations
1
NIDDK-Phoenix Epidemiology and Clinical Research
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
First Nations Community Health Source
Albuquerque, New Mexico, United States, 87108
Actively Recruiting
3
Zuni Health Initiative Center
Black Rock, New Mexico, United States, 87327
Actively Recruiting
Research Team
M
Mark L Unruh, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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