American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Recruiting · NCT04185844 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of New Mexico
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Glomerular Filtration Rate (GFR): eGFR of =\>61\<80 and microalbuminuria \> 30 or eGRF of =\<60 (no microalbuminuria required).
Exclusion criteria
- Unable or unwilling to provide informed consent
- life expectancy \<3 years;
- institutionalized subjects;
- End stage renal disease or renal transplant;
- renal cancer;
- myeloma;
- 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.
Where it is running
3 locations listed across 2 US states.
- NIDDK-Phoenix Epidemiology and Clinical Research - Phoenix, Arizona, United States
- First Nations Community Health Source - Albuquerque, New Mexico, United States
- Zuni Health Initiative Center - Black Rock, New Mexico, United States