NCT04185844

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Aug 2020Jun 2028

First Submitted

Initial submission to the registry

November 22, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

7.8 years

First QC Date

November 22, 2019

Last Update Submit

May 14, 2025

Conditions

Diabetes MellitusChronic Kidney DiseasesHeart DiseasesCardiovascular Diseases

Outcome Measures

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.

    5 years

Secondary Outcomes (4)

  • Onset of End Stage Renal Disease

    5 years

  • Significant loss of renal function

    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

    5 years

  • Slope of change in proteinuria over time

    5 years

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

American Indians at 3 sites.

You may qualify if:

  • Glomerular Filtration Rate (GFR): eGFR of =\>61\<80 and microalbuminuria \> 30 or eGRF of =\<60 (no microalbuminuria required).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NIDDK-Phoenix Epidemiology and Clinical Research

Phoenix, Arizona, 85016, United States

NOT YET RECRUITING

First Nations Community Health Source

Albuquerque, New Mexico, 87108, United States

RECRUITING

Zuni Health Initiative Center

Black Rock, New Mexico, 87327, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine serum, plasma, DNA, RNA

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, ChronicHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark L Unruh, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark L Unruh, MD

CONTACT

505-272-8300MLUnruh@salud.unm.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

December 4, 2019

Study Start

August 31, 2020

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

US(3)