Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Kidney Insufficiency
  • Acute Kidney Failure
  • Acute Renal Failure
  • Acute Renal Injury
  • Acute Renal Insufficiency
  • Chronic Kidney Diseases
  • Chronic Kidney Insufficiency
  • Chronic Renal Diseases
  • Kidney Insufficiency, Chronic
  • Renal Failure, Acute
  • Chronic Renal Insufficiency
  • Kidney Failure, Acute
  • Kidney Insufficiency, Acute
  • Renal 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
  • Indiana University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Princeton University
  • University of Pittsburgh
  • University of Michigan
  • Icahn School of Medicine at Mount Sinai
  • Brigham and Women's Hospital
  • Broad Institute
  • The University of Texas Health Science Center at San Antonio
  • The Cleveland Clinic
  • Columbia University
  • Ohio State University
  • European Molecular Biology Laboratory
  • University of California, San Francisco
  • Yale University
  • Johns Hopkins University
  • Pacific Northwest National Laboratory
  • Stanford University
  • Washington University School of Medicine
  • University of California, San Diego
  • Joslin Diabetes Center
  • University of Texas
Investigators
Principal Investigator: Jonathan Himmelfarb, MD University of Washington