Actively Recruiting

Age: 21Years - 80Years
All Genders
ID04185844

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

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

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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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