Kidney Precision Medicine Project

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:

• Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year

• Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year

• Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)

• International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes

• Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding subjects with acute medical illnesses and changing kidney function:

• Estimated glomerular filtration rate 30-59 mL/min/1.73m2

• Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day)

• Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)

• Diagnosis of hypertension (HTN) established by at least one of the following criteria:

• BP greater than 140/90 mmHg measured on three occasions over at least 1 month

• Taking antihypertensive medication for blood pressure (BP) control

• International Classification of Diseases (ICD) 9/10 diagnostic code for hypertension

• Evidence of persistent kidney damage, manifested as any of the following present on at least two assessments at least 3 months apart and excluding subjects with acute medical illnesses and changing kidney function:

• Estimated glomerular filtration rate 30-59 mL/min/1.73m2 on two assessments at least 3 months apart with albuminuria or proteinuria less than 2000 mg/g creatinine (or mg/day)

• Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine albumin excretion 30-2000 mg/g creatinine (or mg/day)

• Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine protein excretion 150-2000 mg/g creatinine (or mg/day)

• All three of the following criteria must be met:

• Baseline estimated glomerular filtration rate greater than 45 mL/min/1.73m2. Baseline defined by the median of the last three outpatient serum creatinine measurements from day 7 to 365 prior to enrollment.

• If only two measurements obtained within this window, the two results will be averaged.

• If only one measurement was obtained within this window, this result will be used

• If baseline is missing the potential participant can be enrolled with an estimated baseline, but only if there is no past medical history of chronic kidney disease.

• Elevated serum creatinine (greater than or equal to 1.5 times baseline as defined above).

• And at least ONE of the following:

• A repeat serum creatinine within 48 hours of initial serum creatinine, showing a further increase of 0.3 mg/dL

• Positive kidney injury urine biomarker, as defined by any of the following:

• NGAL level greater than or equal to 150 ng/mL by ELISA or clinical analyzer

• KIM1 level greater than or equal to 2.8 ng/mL by ELISA

• TIMP2 x IGFBP7 greater than or equal to 2.0 by NephroCheck®

• Urine microscopy suggestive of acute tubular necrosis defined as a urine microscopy score of greater than or equal to 2.

• greater than or equal to 1 Renal Tubular Epithelial cells (RTE) per high powered field (HPF) AND greater than or equal to 1 granular cast/ low powered field (LPF); or

• greater than or equal to 5 Renal Tubular Epithelial cells (RTE) per high powered field (HPF); or

• greater than or equal to 5 granular cast/ low powered field (LPF)

Locations
United States
Connecticut
Yale University
Recruiting
New Haven
Massachusetts
Brigham & Women's Hospital
Recruiting
Boston
Joslin Diabetes Center
Recruiting
Boston
Maryland
Johns Hopkins University
Recruiting
Baltimore
New York
Columbia University
Recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
Pennsylvania
University of Pittsburgh
Recruiting
Pittsburgh
Texas
University of Texas at Southwestern
Recruiting
Dallas
Contact Information
Primary
Ashveena Dighe, MS, MPH
ashveena@nephrology.washington.edu
206-744-4029
Backup
Kristina Blank, MPH
blankk@uw.edu
206-897-1957
Time Frame
Start Date: September 1, 2019
Estimated Completion Date: June 30, 2027
Participants
Target number of participants: 1000
Treatments
Acute Kidney Injury Cohort
The focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN). KPMP will also include a special population of patients at risk for AKI or with early AKI captured by an open (surgical) kidney biopsy performed at the time of clinically indicated laparotomy.
Chronic Kidney Diseases Cohort
High priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD). A special population of people with long-standing type 1 diabetes (more than 25 years) who remain free of clinically-evident DKD will also be included.
Sponsors
Leads: University of Washington
Collaborators: Princeton University, University of California, San Diego, Pacific Northwest National Laboratory, University of Texas, Washington University School of Medicine, Columbia University, Yale University, Broad Institute, Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Ohio State University, University of Pittsburgh, University of California, San Francisco, The Cleveland Clinic, Joslin Diabetes Center, Stanford University, Brigham and Women's Hospital, Indiana University, European Molecular Biology Laboratory, Icahn School of Medicine at Mount Sinai, The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov

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