Study on chronic kidney disease in American Indian populations
American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
This study looks at chronic kidney disease and heart problems in American Indians to see what makes their health different and to gather important health information for future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT04185844 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding chronic kidney disease (CKD) and cardiovascular disease (CVD) among American Indians in the Southwestern United States. It aims to identify unique risk factors for CKD progression and compare event rates between American Indians and other populations. Participants will undergo a series of assessments including medical history, blood tests, and questionnaires to gather comprehensive health data. The study will also establish a specimen bank for future research on biomarkers related to CKD progression.
Who should consider this trial
Good fit: Ideal candidates are American Indian individuals with an eGFR between 61 and 80 with microalbuminuria or an eGFR of 60 or lower.
Not a fit: Patients with end-stage renal disease, renal cancer, or those unable to participate in study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of chronic kidney disease in American Indian communities.
How similar studies have performed: While there have been studies on CKD and CVD in various populations, this specific focus on American Indian communities is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 2 other locations
- NIDDK-Phoenix Epidemiology and Clinical Research — Phoenix, Arizona, United States (Not_yet_recruiting)
- First Nations Community Health Source — Albuquerque, New Mexico, United States (Recruiting)
- Zuni Health Initiative Center — Black Rock, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Mark L Unruh, MD — University of New Mexico
- Study coordinator: Mark L Unruh, MD
- Email: MLUnruh@salud.unm.edu
- Phone: 505-272-8300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.