RECRUITING

Kidney Precision Medicine Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Despite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by: Non-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD. A number of research centers across the United States are collaborating to bring state-of-the-art technologies together to: * Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD * Define disease subgroups * Create a kidney tissue atlas * Identify critical cells, pathways, and targets for novel therapies The KPMP is made up of three distinct, but highly interactive, activity groups: * Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy. * Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue. * Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.

Official Title

Kidney Precision Medicine Project

Quick Facts

Study Start:2019-09-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04334707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Under 18 years of age
  2. * Body Mass Index (BMI) greater than 40 kg/m2
  3. * Allergy to iodinated contrast (any reaction)
  4. * Pregnancy
  5. * Malignancy - Receiving active chemotherapy or radiation to treat malignancy (except for nephrectomy tissue for reference and feasibility studies)
  6. * Transplant recipient (includes solid transplant and bone marrow)
  7. * Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
  8. * Inability to provide informed consent
  9. * Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD
  10. * Unwilling to receive blood transfusion (if needed)

Contacts and Locations

Study Contact

Ashveena Dighe, MS, MPH
CONTACT
206-744-4029
ashveena@nephrology.washington.edu
Kristina Blank, MPH
CONTACT
206-897-1957
blankk@uw.edu

Principal Investigator

Jonathan Himmelfarb, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06520
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
Joslin Diabetes Center
Boston, Massachusetts, 48374
United States
Columbia University
New York, New York, 10027
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Texas at Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Jonathan Himmelfarb, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2019-09-01
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Kidney Failure
  • Acute Kidney Insufficiency
  • Acute Renal Failure
  • Acute Renal Injury
  • Acute Renal Insufficiency
  • Kidney Failure, Acute
  • Kidney Insufficiency, Acute
  • Renal Failure, Acute
  • Renal Insufficiency, Acute
  • Chronic Kidney Diseases
  • Chronic Kidney Insufficiency
  • Chronic Renal Diseases
  • Chronic Renal Insufficiency
  • Kidney Insufficiency, Chronic