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. Author manuscript; available in PMC: 2010 Jun 1.
Published in final edited form as: Am J Kidney Dis. 2009 Jun;53(6):932–935. doi: 10.1053/j.ajkd.2009.02.011

Table.

Comparison of methods used to develop ethnicity coefficients for the Modification of Diet in Renal Disease Study equation.

MDRD Study (87% whites, 13% African Americans) (2, 28) Chinese Study(3) Japanese Study(4)
Ethnicity Coefficient 1.0 in American whites, 1.21 in African Americans 1.23 in native Chinese 0.81 in native Japanese

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)

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.

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)

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)

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.