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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Chronic Kidney 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Mark L Unruh, MD; Phone Number: 505-272-8300; Email: MLUnruh@salud.unm.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Not yet recruiting
      • NIDDK-Phoenix Epidemiology and Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • First Nations Community Health Source
    • Black Rock, New Mexico, United States, 87327
      • Recruiting
      • Zuni Health Initiative Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

American Indians at 3 sites.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of End Stage Renal Disease	The measure is reflected in decline of GFR levels	5 years
Significant loss of renal function	The measure is reflected in decline of GFR levels	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	5 years
Slope of change in proteinuria over time	The changes in the levels of proteinuria overtime	5 years

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Mark L Unruh, MD, University of New Mexico

Publications and helpful links

Helpful Links

• Chronic Renal Insufficiency cohort study

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 19-159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No