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

Study acronym: AI-CRIC
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Jun 30, 2028 → Jul 31, 2028
See other at-risk trials from University of New Mexico

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2028 to Jul 31, 2028 Show 4 more changesShow less
    • Enrollment target: 500 to 504
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 7 words
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Apr 30, 2025 to Jun 30, 2028
    • Study completion date: Jun 30, 2025 to Jun 30, 2028
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Apr 30, 2024 to Apr 30, 2025
    • Study completion date: Jun 30, 2024 to Jun 30, 2025
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since May 23, 2022, no change to tracked fieldsv5-v6
  2. Primary completion date: Apr 2024 to Apr 30, 2024
    • Study completion date: Jun 2024 to Jun 30, 2024
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2020 to Aug 31, 2020
    • Site details revised at 3 of 3 sites
    • Collaborators shortened, about 22 words
    v3
  4. Start date: Jan 6, 2020 to Jun 2020
    • Primary completion date: Jan 1, 2024 to Apr 2024
    • Study completion date: Jun 30, 2024 to Jun 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04185844
Lead Sponsor University of New Mexico
Conditions
(from sponsor)		 Diabetes Mellitus, Chronic Kidney Diseases, Heart Diseases, Cardiovascular Diseases
Related terms Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Renal Insufficiency, Chronic
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov