Minnesota Precision Medicine CKD & Resilient Diabetes Recruiting Site: Engagement, Enrollment & Ethics

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PROJECT SUMMARY Chronic kidney disease (CKD) is an important health problem associated with high morbidity and mortality. Unraveling the mechanisms associated with risk of or protection from CKD will significantly advance a precision- medicine approach to CKD prevention, diagnosis, and treatment. The Minnesota-KPMP (Minn-KPMP) will ethically and safely obtain research kidney biopsies, biosamples, and data from well phenotyped participants with CKD due to diabetes or hypertension and from patients with no clinical manifestations of CKD despite decades of type 1 diabetes (T1D). In a highly diverse metropolitan area actively confronting racism and disparities, Minn-KPMP will engage a diverse patient population to evaluate and address barriers to enrollment in KPMP and to elicit the perspectives of our local participants on ethical issues posed by the KPMP, such as return of results and biobank governance. This will add significantly to KPMP community engagement and ethics. Leveraging the Biomedical Informatics and Data Access service of the University of Minnesota Clinical and Translational Science Institute (CTSI) Best Practices Integrated Informatics Core (BPIC), we will interrogate the large MHealth Fairview (MHealth) database to identify, recruit, enroll, and obtain clinical data, biosamples, and kidney biopsies from patients with CKD-Diabetes and CKD-Hypertension and resilient-T1D. We will work closely with KPMP and help to refine and follow common study protocols while following maximum safety precautions. The long-standing successful track record of our group in recruiting patients into clinical trials of CKD, and our ethically rigorous approach to consenting for kidney biopsy and strict adherence to KPMP safety measures will ensure our meaningful contribution to the KPMP mission and goals. Minn-KPMP has assembled an outstanding team of investigators and consultants to recruit and follow participants with CKD and with resilient T1D (Res-T1D). Directly relevant to this application, the Minn-KPMP study team has a long-standing track record of successfully recruiting, following-up, and safely and ethically performing research kidney biopsies, including sequential kidney biopsies, in a wide range of participants, including participants with diabetes and with no clinical manifestations of CKD, siblings with diabetes, kidney donors, kidney transplant recipients, and pancreas transplant recipients. Obtaining high quality biosamples, including kidney biopsy samples, from well phenotyped study participants is key to KPMP success, so that these tissues can be used for transcriptomic, proteomic, and metabolomic analyses. The Minn-KPMP is eager and fully prepared to collaborate with the other KPMP recruiting sites, tissue interrogation sites, central hub, steering committee, DSMB, external expert panel, and the almost 300 members of the KPMP.