American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-80
SponsorUniversity of New Mexico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Glomerular Filtration Rate (GFR): eGFR of =>61<80 and microalbuminuria > 30 or eGRF of =<60 (no microalbuminuria required).
Disqualifiers
Unable or unwilling to provide informed consent
life expectancy <3 years;
institutionalized subjects;
End stage renal disease or renal transplant;
Trial population
American Indians at 3 sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSecondary outcomes
1
Onset of End Stage Renal Disease
The measure is reflected in decline of GFR levels
Time frame
5 years2
Significant loss of renal function
The measure is reflected in decline of GFR levels
Time frame
5 years3
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
Time frame
5 years4
Slope of change in proteinuria over time
The changes in the levels of proteinuria overtime
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov