Kidney Precision Medicine Project
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Kidney Failure
- Acute Kidney Insufficiency
- Acute Renal Failure
- Acute Renal Injury
- Acute Renal Insufficiency
- Chronic Kidney Diseases
- Chronic Kidney Insufficiency
- Kidney Insufficiency, Chronic
- Renal Failure, Acute
- Chronic Renal Diseases
- Chronic Renal Insufficiency
- Kidney Failure, Acute
- Renal Insufficiency, Acute
- Kidney Insufficiency, Acute
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The Kidney Precision Medicine Project (KPMP) is a prospective cohort study, whose goal is to use deep molecular phenotypes of kidney biopsies, along with longitudinally collected clinical phenotypic data, in order to develop new disease ontologies, classification systems, and treatments for acute ki...
The Kidney Precision Medicine Project (KPMP) is a prospective cohort study, whose goal is to use deep molecular phenotypes of kidney biopsies, along with longitudinally collected clinical phenotypic data, in order to develop new disease ontologies, classification systems, and treatments for acute kidney injury (AKI) and chronic kidney disease (CKD). Since its inception, the KPMP has sought out and included substantive patient-representative feedback regarding disease experience, lack of innovation in new kidney disease therapies and patient tolerance for risk levels in balance with potential benefits both to the individual and society. The KPMP Has publicly and operationally committed itself to always put participants and their best interests first and this foundational principle informs and undergirds every facet of the study. Both AKI and CKD are conditions that impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. The network will utilize state-of-the-art methods to perform molecular interrogation of the tissue and to link the molecular data to kidney structure and clinical information in the form of a kidney tissue atlas. Molecular and imaging data derived from kidney tissue will be integrated with clinico-pathologic and genetic information, as well as other data derived from analyses of fluid biospecimens, including peripheral blood, urine, and stool. Using advanced analytics to integrate the data, KPMP will aim to define kidney disease subgroups in molecular terms by identifying critical cells, pathways and targets for novel therapies. Patients with AKI or CKD will be recruited from clinical care encounters (e.g., clinic visits for CKD patients, hospitalization or emergency room visits for AKI patients) and from electronic resources (e.g., existing registries, electronic health records). All study procedures are designed to optimize participant safety and will be ethically conducted, ensuring subjects fully understand the scope of the study and any possible risks. For each participant, kidney tissue will be obtained for molecular phenotyping and clinical diagnosis. The diagnostic interpretation will be returned to the participant's primary caregiver to inform clinical care, but no treatment interventions will be prescribed by the KPMP. In addition to kidney biopsy, the study will involve collection of baseline (time of biopsy) and longitudinal biospecimens (including urine, plasma, serum, DNA and stool) and demographic, clinical, and laboratory data. Participants will be followed through scheduled in-person and remote (telephone) study visits, as well as through periodic review of electronic health records.
Tracking Information
- NCT #
- NCT04334707
- Collaborators
- Icahn School of Medicine at Mount Sinai
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Michigan
- Brigham and Women's Hospital
- The University of Texas Health Science Center at San Antonio
- Broad Institute
- Pacific Northwest National Laboratory
- University of California, San Francisco
- Yale University
- University of Texas
- Ohio State University
- University of California, San Diego
- The Cleveland Clinic
- Columbia University
- European Molecular Biology Laboratory
- Indiana University
- Johns Hopkins University
- Stanford University
- University of Pittsburgh
- Princeton University
- Joslin Diabetes Center
- Washington University School of Medicine
- Investigators
- Principal Investigator: Jonathan Himmelfarb, MD University of Washington