Kidney Precision Medicine Project

Launched by UNIVERSITY OF WASHINGTON · Apr 1, 2020

Keywords

ClinConnect Summary

The Kidney Precision Medicine Project (KPMP) is a clinical trial aimed at understanding and finding better treatments for acute kidney injury (AKI) and chronic kidney disease (CKD). Right now, there are very few effective therapies available for these conditions, and this study hopes to change that by collecting and analyzing kidney tissue from participants. Researchers believe that AKI and CKD are not just single diseases but can actually have different causes and pathways. By studying kidney biopsies, they aim to identify specific disease subgroups and develop targeted therapies that can help improve care for patients.

To participate in the study, individuals must be diagnosed with either acute kidney injury or chronic kidney disease, which often relates to conditions like diabetes or high blood pressure. Key eligibility criteria include having specific levels of kidney function and certain symptoms, such as protein in the urine. Participants will undergo kidney biopsies and will be part of a collaborative effort that includes recruitment, advanced tissue analysis, and data sharing among research centers across the U.S. This research could lead to significant advancements in how we understand and treat kidney diseases.

Gender

ALL

Eligibility criteria

• • Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)
• * 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)
• • Hypertension-associated Chronic Kidney Disease (H-CKD) Inclusion Criteria
• * 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)
• • Acute Kidney Injury Subjects Inclusion Criteria
• 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)
• General Exclusion Criteria:
• • Under 18 years of age
• • Body Mass Index (BMI) greater than 40 kg/m2
• • Allergy to iodinated contrast (any reaction)
• • Pregnancy
• • Malignancy - Receiving active chemotherapy or radiation to treat malignancy (except for nephrectomy tissue for reference and feasibility studies)
• • Transplant recipient (includes solid transplant and bone marrow)
• • Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
• • Inability to provide informed consent
• • Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD
• • Unwilling to receive blood transfusion (if needed)