Status:
RECRUITING
Kidney Precision Medicine Project
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Conditions:
Acute Kidney Failure
Acute Kidney Insufficiency
Eligibility:
All Genders
18+ years
Brief 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. Despit...
Detailed 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 d...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04334707
Start Date
September 1 2019
End Date
June 30 2027
Last Update
May 19 2022
Active Locations (8)
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1
Yale University
New Haven, Connecticut, United States, 06520
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
4
Joslin Diabetes Center
Boston, Massachusetts, United States, 48374