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

Cardiovascular Diseases Clinical Trial

— AI-CRIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185844
• Other study ID #: 19-159
• Status: Recruiting
• Start date: August 31, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: Mark L Unruh, MD
• Phone: 505-272-8300
• Email: MLUnruh[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus
• Heart Diseases
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	First Nations Community Health Source	Albuquerque	New Mexico
United States	Zuni Health Initiative Center	Black Rock	New Mexico
United States	NIDDK-Phoenix Epidemiology and Clinical Research	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Onset of End Stage Renal Disease	The measure is reflected in decline of GFR levels	5 years
Secondary	Significant loss of renal function	The measure is reflected in decline of GFR levels	5 years
Secondary	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
Secondary	Slope of change in proteinuria over time	The changes in the levels of proteinuria overtime	5 years

External Links

•   Chronic Renal Insufficiency cohort study