Diabetes MellitusAI-CRICNCT04185844
American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
An observational study of Diabetes Mellitus and Chronic Kidney Diseases, run by University of New Mexico at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Chronic Kidney Diseases, Heart Diseases
- How many people
- 504 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2020to 31 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: American Indians at 3 sites.
Who may be able to join
- Glomerular Filtration Rate (GFR): eGFR of =>61<80 and microalbuminuria > 30 or eGRF of =<60 (no microalbuminuria required).
Who cannot join
- Unable or unwilling to provide informed consent
- life expectancy <3 years;
- institutionalized subjects;
- End stage renal disease or renal transplant;
- renal cancer;
- myeloma;
Show all 12Show fewer
- immunosuppression;
- Polycystic kidney disease;
- participation in any clinical trial,
- current pregnancy
- current incarceration.
- Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
First Nations Community Health Source
Albuquerque, New Mexico, 87108
- Recruiting
Zuni Health Initiative Center
Black Rock, New Mexico, 87327
- Not yet recruiting
NIDDK-Phoenix Epidemiology and Clinical Research
Phoenix, Arizona, 85016
About this study
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.
Read the 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
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Heart Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of the GFR
Primary outcomes regarding Cardio vascular disease will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD.
Measured: 5 years
Secondary outcomes (4)
Onset of End Stage Renal Disease
The measure is reflected in decline of GFR levels
Measured: 5 years
Significant loss of renal function
The measure is reflected in decline of GFR levels
Measured: 5 years
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
The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline
Measured: 5 years
Slope of change in proteinuria over time
The changes in the levels of proteinuria overtime
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start31 Aug 2020
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark L Unruh, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185844
- Sponsor's protocol ID
- 19-159
- Acronym
- AI-CRIC
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No