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American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
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.
Conditions:
🦠 Diabetes Mellitus 🦠 Chronic Kidney Diseases 🦠 Heart Diseases 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 31 August 2020
🗓️ Primary Completion (Estimated) 30 April 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Phoenix, Arizona, United States
📍 Albuquerque, New Mexico, United States
📍 Black Rock, New Mexico, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 November 2019
  • First Submitted that Met QC Criteria 2 December 2019
  • First Posted 4 December 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 March 2024
  • Last Update Posted 18 March 2024
  • Last Verified March 2024
I'm interested ...!!