Kidney Precision Medicine Project

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: o Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year o 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 people with acute medical illnesses and changing kidney function: * Estimated glomerular filtration rate 30-59 mL/min/1.73m2 or * Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day) or * Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day) * Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m\^2. Hypertension-associated Chronic Kidney Disease (H-CKD) * 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 people 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 less than or equal to 2000 mg/g creatinine (or mg/day), or proteinuria less than or equal to 3000 mg/g creatinine (or mg/day), or ≤1+ proteinuria on urinalysis, or * Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion 30-2000 mg/g creatinine (or mg/day) or * Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion 150-3000 mg/g creatinine (or mg/day) * Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m2 Acute Kidney Injury Inclusion Criteria 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 are 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. * If the AKI RS PI believes that the baseline serum creatinine under or over-estimates baseline, a unanimous vote of AKI site PIs can confirm eligibility based on a review of deidentified serum creatinine values provided by the site PI. AND ONE of the following criteria must be met: * Drop in urine output (\<500 ml/24 hours) * Any rise in serum creatinine ≥0.3 mg/dl over the baseline serum creatinine * A rise in serum creatinine \>0.1 mg/dl in a patient with high risk of AKI and at least one of the following: * 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. \[25\] ▪ 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) Type 1 Diabetes Inclusion Criteria Clinical diagnosis of T1D without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.), reviewed and approved by KPMP site endocrinologist, and supported by at least one of the following: One or more positive antibodies associated with T1D • Low C-peptide, defined as at least one of the following: * Prior/historical test undetectable (below lower limit of assay) * C peptide \<0.6 ng/ml if estimated glomerular filtration rate (eGFR) ≥60 mL/min per 1.73m2 and use of multiple daily insulin injections or insulin pump use for \>1 year * C peptide \<2.0 ng/ml if eGFR \<60 mL/min per 1.73m2 and use of multiple daily insulin injections or insulin pump use for \>1 year • Diabetes mellitus diagnosis for 5 years and complex insulin defined by multiple daily insulin injections ( 3 or more) or basal insulin injection plus inhaled insulin for meals or insulin pump therapy \> 1 year continuously AND one of the following (CKD, at risk of CKD, or DM-R): * CKD: 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 people with acute medical illnesses and changing kidney function: o eGFR 30-59 mL/min per 1.73m2 or o eGFR greater than or equal to 30 mL/min per 1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day) * eGFR greater than or equal to 30 mL/min per 1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/da