American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Sponsor

University of New Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04185844

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

166.7

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Chronic Kidney Diseases Heart Diseases Cardiovascular Diseases

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Actual Study Start Date :

Aug 31, 2020

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

Slope of the GFR [5 years]
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.

Secondary Outcome Measures

Onset of End Stage Renal Disease [5 years]
The measure is reflected in decline of GFR levels
Significant loss of renal function [5 years]
The measure is reflected in decline of GFR levels
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 [5 years]
The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline
Slope of change in proteinuria over time [5 years]
The changes in the levels of proteinuria overtime

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NIDDK-Phoenix Epidemiology and Clinical Research	Phoenix	Arizona	United States	85016
2	First Nations Community Health Source	Albuquerque	New Mexico	United States	87108
3	Zuni Health Initiative Center	Black Rock	New Mexico	United States	87327