Recruiting

Observational Study

Sponsor:

University of New Mexico

Code:

NCT04185844

Conditions

Diabetes Mellitus

Chronic Kidney Diseases

Heart Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Diabetes Mellitus

Chronic Kidney Diseases

Heart Diseases

Cardiovascular Diseases

Study ID

NCT04185844

Start date

Aug 31, 2020

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Slope of the GFR [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Mark L Unruh, MD

505-272-8300MLUnruh@salud.unm.edu

Locations

First Nations Community Health Source

Recruiting

Albuquerque, New Mexico, United States, 87108

Zuni Health Initiative Center

Recruiting

Black Rock, New Mexico, United States, 87327

More Information

Sponsor

University of New Mexico

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-05-20.