Introduction
Preparation procedure
Background
CKD progressing slowly | CKDa progressing fast | |
---|---|---|
Early stage: CKD G1–G3a (eGFR ≥ 45 ml/min per 1.73 m2) | Slope of mGFR or eGFR or surrogate outcomeb or combinations of outcomes | 30–40% decline in eGFR using repeat measurements to rule out transient acute effectsc |
Late stage: CKD G3b–G5 (eGFR < 45 ml/min per 1.73 m2) | End-stage kidney disease or 30%~40% decline in eGFRc | End-stage kidney disease or doubling of serum creatinine level (or 40%~57% decline in eGFR)c |
Relation between decrease in estimated glomerular filtration rate in Japanese CKD patients and risks of end-stage renal disease: analysis of CKD-JAC
Methods
Study population
Change in eGFR
ESRD (end-stage renal disease)
Covariates
Statistical analysis
Results
Percentage change in eGFR over 1 year (%) | ||||
---|---|---|---|---|
≤ − 53 | > − 53 to ≤ − 30 | > − 30 to ≤ 0 | > 0 | |
No. of subjects | 34 | 199 | 1375 | 802 |
ESRD event, n (%) | 30 (88.2) | 133 (66.8) | 256 (18.6) | 79 (9.9) |
Age, mean (SD), age | 60.1 (11.8) | 61.3 (11.4) | 60.9 (11.5) | 61.5 (11.1) |
Female, n (%) | 21 (61.8) | 135 (67.8) | 840 (61.1) | 501 (62.5) |
Smoker, n (%) | 3 (8.8) | 39 (19.6) | 202 (14.7) | 102 (12.7) |
DM, n (%) | 18 (52.9) | 107 (53.8) | 498 (36.2) | 268 (33.4) |
History of cardiovascular disease, n (%) | 6 (17.6) | 53 (26.6) | 285 (20.7) | 190 (23.7) |
Total cholesterol, mean (SD), mmol/L | 5.5 (1.8) | 5.1 (1.3) | 5 (1.1) | 4.9 (1.1) |
SBP, mean (SD), mmHg | 140.1 (21.5) | 138.1 (18.6) | 132.1 (17.9) | 127.6 (17.7) |
DBP, mean (SD), mmHg | 76.6 (10.2) | 76.9 (12.3) | 76.9 (12) | 74.7 (11.5) |
Use of antihypertensive drug, n (%) | 34 (100) | 197 (99) | 1316 (95.7) | 741 (92.4) |
eGFR, mean (SD), ml/min/1.73 m2 | 22.3 (10.7) | 20 (12.2) | 28.2 (14.9) | 28.5 (14.8) |
Albuminuria, median (interquartile range), Alb mg/gCr | 2663.3 (1205.5, 4070.9) | 1688.7 (849.4, 3241.2) | 627.4 (180.2, 1298.2) | 186.7 (41.4, 559.5) |
Hemoglobin, mean (SD), g/dL | 10.5 (1.4) | 11.1 (1.6) | 12.2 (1.8) | 12.2 (1.8) |
Percentage change in eGFR over 2 years (%) | ||||
---|---|---|---|---|
≤ − 53 | > − 53 to ≤ − 30 | > − 30 to ≤ 0 | > 0 | |
No. of subjects | 87 | 314 | 1153 | 525 |
ESRD event, n (%) | 71 (81.6) | 154 (49) | 104 (9) | 36 (6.9) |
Age, mean (SD), age | 59.9 (10.6) | 61.3 (11.6) | 60.7 (11.2) | 60.9 (11.4) |
Female, n (%) | 54 (62.1) | 210 (66.9) | 670 (58.1) | 332 (63.2) |
Smoker, n (%) | 16 (18.4) | 56 (17.8) | 153 (13.3) | 65 (12.4) |
DM, n (%) | 44 (50.6) | 145 (46.2) | 378 (32.8) | 173 (33) |
History of cardiovascular disease, n (%) | 25 (28.7) | 82 (26.1) | 221 (19.2) | 117 (22.3) |
Total cholesterol, mean (SD), mmol/L | 5.2 (1.4) | 5.1 (1.1) | 5 (1.1) | 5 (1.1) |
SBP, mean (SD), mmHg | 137.8 (19.7) | 136.5 (16.5) | 130.5 (17.3) | 125.5 (17.8) |
DBP, mean (SD), mmHg | 76.7 (12.2) | 77.3 (12) | 76.5 (11.4) | 74.4 (11.9) |
Use of antihypertensive drug, n (%) | 86 (98.9) | 312 (99.4) | 1092 (94.7) | 481 (91.6) |
eGFR, mean (SD), ml/min/1.73 m2 | 24.4 (11.1) | 22.2 (11.2) | 30 (14.9) | 30 (15) |
Albumin-to-creatinine ratio, median (interquartile range), mg/g | 1602.8 (956.7, 3262.3) | 1292.4 (604, 2291.6) | 482.1 (130.1, 1049.8) | 128.3 (29.9, 408.9) |
Hemoglobin, mean (SD), g/dL | 11.2 (1.7) | 11.6 (1.6) | 12.3 (1.7) | 12.4 (1.9) |
Discussion
Conclusion
Assessment of percentage change in eGFR as surrogate endpoint for end-stage renal disease: analysis of data of general health examinations in Okinawa prefecture and ORIENT study
Epidemiological study
Method
Data
Statistical analyses
Results
All | High-eGFR group | Low-eGFR group | |
---|---|---|---|
N (%) | 69,238 | 58,292 (84.2) | 10,946 (15.8) |
Male (%) | 29,744 (43.0) | 25,958 (44.5) | 3786 (34.6) |
Age (years) | 55.6 ± 14.7 | 53.19 ± 14.2 | 68.39 ± 10.2 |
BMI (kg/m2) | 24.1 ± 3.4 | 24.05 ± 3.4 | 24.27 ± 3.3 |
SBP (mmHg) | 127.8 ± 17.4 | 126.68 ± 17.2 | 133.77 ± 17.4 |
Total cholesterol level (mg/dl) | 204.3 ± 35.6 | 203.1 ± 35.5 | 210.7 ± 35.9 |
Urinary protein (%) | |||
− | 66,737 (96.4) | 56,543 (97) | 10,194 (93.1) |
± | 1671 (2.4) | 1224 (2.1) | 447 (4.1) |
1 + or more | 830 (1.2) | 525 (0.9) | 305 (2.8) |
eGFR (ml/min/1.73 m2) | 80.2 ± 21.2 | 85.4 ± 18.7 | 52.4 ± 7.0 |
Percentage change in eGFR over 1 year (%/year) | 1.0 ± 19.4 | 0.8 ± 19.5 | 2.0 ± 19.0 |
Percentage change in eGFR over 2 years (%/2 years) | 0.5 ± 20.9 | 0.1 ± 19.5 | 2.6 ± 27.0 |
Percentage change in eGFR over 3 years (%/3 years) | − 0.3 ± 21.3 | − 2.4 ± 20.2 | 10.7 ± 23.5 |
ESRD risk (%) | 383 (0.55) | 186 (0.32) | 197 (1.8) |
Clinical study
Method
Data
Analysis
Results
Olmesartan group | Control group | |
---|---|---|
Number of cases | 282 | 284 |
Age (years) | 59.1 ± 8.1 | 59.2 ± 8.1 |
Country (Japan/China) | 182/100 | 184/100 |
Male (%) | 199 (70.6) | 192 (67.6) |
Smoking (%) | 72 (25.5) | 72 (25.4) |
BMI (kg/m2) | 25.3 ± 4.2 | 25.3 ± 3.8 |
SBP (mmHg) | 141.7 ± 17.0 | 140.8 ± 18.0 |
DBP (mmHg) | 77.8 ± 10.4 | 77.2 ± 10.6 |
Albuminuria (mg/mmol) | 192.3 (87.1, 339.4) | 191.2 (98.4, 352.9) |
HbA1c (%) | 7.1 ± 1.2 | 7.1 ± 1.2 |
eGFR (ml/min/1.73 m2) | 37.1 ± 9.6 | 37.1 ± 10.0 |
Percentage change in eGFR over 1 year (%/year) | − 19.2 ± 18.2 | − 18.4 ± 17.0 |
Percentage change in eGFR over 2 years (%/2 years) | − 27.8 ± 22.1 | − 28.4 ± 21.1 |
Percentage change in eGFR over 3 years (%/3 years) | − 29.2 ± 22.2 | − 32.3 ± 21.7 |
ESRD risk (%) | 74 (26.2) | 78 (27.5) |
Discussion
Conclusion
Systematic review
CQ1: What is the appropriate level of decline in GFR as a surrogate endpoint of end-stage renal disease?
Background
Literature search
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(“glomerular filtration rate”[MeSH Terms] OR (“glomerular”[All Fields] AND “filtration”[All Fields] AND “rate”[All Fields]) OR “glomerular filtration rate”[All Fields]) AND ((“kidney failure, chronic”[MeSH Terms] OR (“kidney”[All Fields] AND “failure”[All Fields] AND “chronic”[All Fields]) OR “chronic kidney failure”[All Fields] OR (“end”[All Fields] AND “stage”[All Fields] AND “renal”[All Fields] AND “disease”[All Fields]) OR “end-stage renal disease”[All Fields]) OR (“kidney failure, chronic”[MeSH Terms] OR (“kidney”[All Fields] AND “failure”[All Fields] AND “chronic” [All Fields]) OR “chronic kidney failure”[All Fields] OR (“end”[All Fields] AND “stage”[All Fields] AND “kidney”[All Fields] AND “disease”[All Fields]) OR “end-stage kidney disease” [All Fields])) AND decline[All Fields] AND (“1970/01/01”[PDAT]: “2016/12/31”[PDAT]).