The current understanding of the pathophysiologic and socio-economic processes that initiate CKD and the paths by which they progress to ESRD are poorly understood, resulting in limited treatments. There is a compelling unmet need for prospective studies to accurately phenotype patients with CKD using a combination of kidney biopsy, clinical, biologic, and socioeconomic factors to develop individualized care to improve patient outcomes. We are currently conducting the largest pragmatic trial in CKD sponsored by the NIH Collaboratory for Health Care Systems (HCS) Research using novel electronic health records (EHR) - based informatics to identify and facilitate care for patients with CKD, diabetes and hypertension, including large numbers of underserved patients. We now propose a prospective cohort study (Precise-CKD) in patients with CKD as part of the Kidney Precision Medicine Program (KPMP). We hypothesize that our large and diverse HCS will successfully obtain kidney biopsies, biosamples and clinical data from patients with CKD and that with that approach we will identify disease subgroups and contribute to the creation of a kidney tissue atlas as part of the KPMP. In the Planning Phase UG 3 of this proposal we will use our existing, fully functioning, novel information technology tools leveraging our electronic health record systems to identify, recruit, enroll and obtain clinical data, biosamples and kidney biopsies from patients with CKD-Diabetes and CKD-Hypertension from 3 large HCS. We will engage community and patient stakeholders to develop ethically-sound, patient-centered processes to engage patients with CKD in the study and obtain consent for kidney biopsies. We will work closely with KPMP to develop common study protocols and following maximum safety precautions we will obtain high quality kidney biopsies from 40 patients. In the Implementation Phase UH3 we will increase recruitment and obtain kidney biopsies, biosamples and clinical data from an additional 400 patients with CKD-diabetes and CKD-HTN adding another large HCS. We will also expand the cohort of CKD patients likely to yield actionable results based on high risk for progression (eGFR decline >30% over 2 years), novel imaging findings (fMRI or SPECT from UTSW) or results from other KPMP investigators from UG3 suggesting probability of identifying therapeutic targets. The long-standing successful track record of our group in recruiting patients into clinical trials of CKD, the large, and diverse patient populations available for recruitment at our site, the fully functioning infrastructure for identifying and recruiting patients from multiple healthcare systems with novel informatics tools, and the ethically rigorous approach to consenting for kidney biopsy coupled with the rigorously safe methodology will facilitate our efforts to contribute to the KPMP.
Patients with chronic kidney disease have a higher risk for early death and kidney failure. At the present time there is no cure for chronic kidney disease. In this study we propose to collect medical and socio-economic information from patients, blood and urine samples and do a kidney biopsy to obtain samples of kidney tissue. That information will be used to understand what leads to the progression of chronic kidney disease and to develop new treatments to avoid future complications in patients.
