Table.
MDRD Study (87% whites, 13% African Americans) (2, 28) | Chinese Study(3) | Japanese Study(4) | |
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Ethnicity Coefficient | 1.0 in American whites, 1.21 in African Americans | 1.23 in native Chinese | 0.81 in native Japanese |
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External Validation | Performed well in several other studies of whites and African Americans with CKD (reasonably unbiased).(21) | Coefficient was inaccurate in a recent Chinese study.(11) | Ethnicity coefficient was similar (0.76) in a prior Japanese study.(5) |
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Serum Creatinine | |||
Mean | 2.1 mg/dl | 2.0 mg/dl (not standardized) | 1.6 mg/dl |
Assay | Enzymatic (standardized) | Kinetic rate alkaline picrate (Jaffe) reaction | Enzymatic (standardized) |
Calibration | Reference assay | Levels adjusted for calibration differences with the MDRD Study laboratory for the Chinese ethnicity coefficient, but not for the separate Chinese equation. This adjustment may not have been accurate.(11) | Levels were slightly lower than standardized assay used to develop MDRD Study equation. No adjustment was made. |
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Glomerular Filtration Rate | |||
Mean | 40 ml/min/1.73 m2 | 55 ml/min/1.73 m2 | 58 ml/min/1.73 m2 |
Exogenous marker | 125I-Iothalamate with SC injection | 99mTc-DTPA with bolus IV injection | Inulin with IV infusion over 2 hours |
Clearance method | Urinary clearance with 4 consecutive urine collections by voluntary voiding (no bladder catheter) and 5 plasma samples after a 1 hour equilibrium period | Plasma clearance with dual plasma sampling method (plasma samples at 2nd and 4th hour) | Urinary clearance with 3 plasma and 3 urine samples over 2 hours |
Patient factors (physiological state) | Fasting except for a 10 ml/kg oral water load (29) | Post-prandial and 300 to 500 ml oral water load (19) | Fasting except for 500 ml oral water load (30) |
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Study Population | |||
Demographics | Mean age 51 years, 60% men | Mean age 50 years, 51% men | Mean age 51 years, 61% men |
Body Surface Area | Mean 1.91 m2 | Mean 1.7 m2 | Mean 1.64 m2 |
Sample Size | 1628 patients | 684 patients | 763 patients |
Target sample | CKD as identified by an elevated SCr level (>1.4 mg/dL in men and >1.2 mg/dL in women) at 15 centers. Extensive exclusion criteria as is common in clinical trials.(31) | CKD as diagnosed by KDOQI guidelines (1) at 9 renal institutes at university hospitals. Persons with skeletal muscle atrophy, edema, heart failure, pleural effusions, or ascites excluded. | Mostly nephrology inpatients at 80 centers undergoing a kidney biopsy or education on life style changes. |
Case Mix (top 4 etiologies) | Glomerular disease, polycystic kidney disease, hypertensive nephrosclerosis, other kidney disease or not specified | Primary or secondary glomerular disease, hypertension, obstructive kidney disease, renovascular disease | Chronic glomerulonephritis, miscellaneous, diabetes mellitus, and nephrosclerosis (kidney donors/recipients also included) |
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Statistical Methods | Regression of logarithmic GFR onto logarithmic SCr with a “African American compared with white ethnicity” indicator variable. | Measured GFR was regressed onto estimated GFR with the intercept forced to 0 and the slope as the Chinese coefficient. | Japanese coefficient calculated by minimizing the root-mean-squared error between measured GFR and estimated GFR. |
Note: Conversion factors for units: serum creatinine in mg/dL to mol/L, x88.4; glomerular filtration rate in ml/min/1.73m2 to ml/s/1.73m2, multiply by 0.01667.
Abbreviations: CKD, chronic kidney disease; GFR, glomerular filtration rate; MDRD, modification of diet in renal disease; KDOQI, Kidney Disease Outcomes Quality Initiative, SC, subcutaneous; IV, intravenous; SCr, serum creatinine.