NCT04185844 American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)
| NCT ID | NCT04185844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of New Mexico |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-08-31 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-08-31 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mark L Unruh, MD
PRINCIPAL INVESTIGATOR
University of New Mexico
Frequently Asked Questions
Who can join the NCT04185844 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04185844 currently recruiting?
Yes, NCT04185844 is actively recruiting participants. Contact the research team at MLUnruh@salud.unm.edu for enrollment information.
Where is the NCT04185844 trial being conducted?
This trial is being conducted at Phoenix, United States, Albuquerque, United States, Black Rock, United States.
Who is sponsoring the NCT04185844 clinical trial?
NCT04185844 is sponsored by University of New Mexico. The principal investigator is Mark L Unruh, MD at University of New Mexico. The trial plans to enroll 500 participants.
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