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Early Detection of
Chronic Kidney Disease
(CKD)
Gregorio T. Obrador, MD, MPH
Dean, Faculty of Health Sciences & School of Medicine
Universidad Panamericana, Mexico City
Adjunct Assistant Professor of Medicine, Tufts University School of Medicine, Boston, MA
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Early Detection of CKD
Epidemiology of CKD in Mexico & CKD prevention
Kidney Early Evaluation (KEEP) Mexico Program
Validation of PoCT measurement of SCr
PoCT testing of albuminuria
Conclusions
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Epidemiology of CKD in Mexico
1At risk
for CKD2 3 4 5
KRT
Dialysis
Kidney Tx
¿How many have
diabetes,
hypertension,
or obesity?
¿How many have CKD?¿How many
receive Rx
with dialysis or Tx?
CKD
1
2
3¿How many with CKD are detected early?
4
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~9% of the Adult Population
has CKD 3-5
CKD 1 62.5% 626,034 pmp
CKD 2 29.0% 289,181 pmp
CKD 3 8.1% 80,788 pmp
CKD 4 0.3% 2,855 pmp
CKD 5 0.1% 1,142 pmp
Amato et al, Kidney Int 68:S11-S17, 2005.
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Estimated Prevalence of CKD 5
2005
Peritoneal dialysis 45,639
Hemodialysis 19,097
No access to KRT 65,006
TOTAL 129,742
M Lòpez, UNAM Study 010
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Projections for CKD 5
129.472139.848
159.625
183.672
212.052
0
50.000
100.000
150.000
200.000
250.000
2005 2010 2015 2020 2025
Pre
vale
nce
Year
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Dialysis Costs
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Kidney Transplants in Mexico
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Waiting List for Kidney
Transplantation
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Diabetes Prevalence Has Doubled
7,5%
14,4%
0%
2%
4%
6%
8%
10%
12%
14%
16%
ENSA 2000 ENSA 2006
23% are unaware
of having DM
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Nephropathy is the Most Expensive
Complication of Diabetes
Globalization and Health 2013, 9:3
Retinopatía
Vascular
Nefropatía
Neuropatía
Cardíaca
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Hypertension Prevalence
30,0% 30,8% 31,5%
18,2%16,5%
14,9%
0%
5%
10%
15%
20%
25%
30%
35%
ENSA 2000 ENSANUT 2006 ENSANUT 2012
Global Finding
47% were unaware
of having HTN
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Almost Half of Diabetic Patients
Also Have Hypertension
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Diabetes & Hypertension Control
Has Improved Over Time
5% 5%
25% 25%
0%
5%
10%
15%
20%
25%
30%
Diabetes Hypertension
2006 2012
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#1 in Adult and Childhood
Overweight & Obesity
%
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Aging of the PopulationLife Expectancy Projections
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CKD Prevention
1NormalRisk
factors2 3 4 5
KRT
Dialysis
Kidney Tx
Primary
PreventionSecondary
Prevention
Tertiary
Prevention
CKD
Prevent development
of CKDEarly detection and
treat complicationsTreat kidney failure
Levey et al. Am J Kidney Dis 53:522-35, 2009.
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Early Detection of CKD
Epidemiology of CKD in Mexico & CKD prevention
Kidney Early Evaluation (KEEP) Mexico Program
Validation of PoCT measurement of SCr
PoCT testing of albuminuria
Conclusions
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Justification of CKD Screening
● CKD is frequent
● It is associated with high morbidity, mortality and cost
● It can be diagnosed with simple and unexpensive tests
● Early detection allows for implementation of
interventions that have been shown to slow progression
to end-stage kidney disease
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Kidney Early Evaluation Program
KEEP Mexico
● It is a CKD screening and educational program aimed at individuals at high risk for CKD, including those with diabetes, hypertension, and/or family history of DM/HTN/CKD
● It was developed by the US National Kidney Foundation in early 2000 and currently is used in Japan and Australia.
● In 2008 the Mexican Kidney Foundation adapted KEEP for use in Mexico
● A pilot began in Mexico City and Guadalajara, Jalisco
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KEEP Mexico
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Publications of KEEP Mexico
Kidney Int 77: S2-S8, 2010
Am J Kidney Dis 57(3): 361-370, 2011
Archives of Medical Research 44:650-54, 2013
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17%
22%
16%
45%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Diabetes Hypertension DM & HTN Family Hx
55%
Risk Factors for CKD
(N = 6116)
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CKD Prevalence
29%
14%
9%
5%
1%
0%
5%
10%
15%
20%
25%
30%
35%
Total Estadio 1 Estadio 2 Estadio 3 Estadio 4-5
Pre
vale
nc
ia d
e E
RC
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39%
29%
55%
15%
0%
10%
20%
30%
40%
50%
60%
Diabetes Hypertension DM & HTN Hx Fam
N= 1028 1345 1001 2742
CKD Prevalence by Risk Factor
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Prior Medical Care &
CKD Awareness
0%
10%
20%
30%
40%
50%
60%
70%
80%
CKD Awareness Visited MD withn 1 year
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86%
60%
48%
35%
8%
34%
14%
5%
6%
31%
4%
1%
7%
58%
50%
4%
50%
100%
0
1
2
3
4
5
CKD o
CKD 1
CKD 2
CKD 3
CKD 4
CKD 5
Transitions in CKD Stage
(N= 434)N ERC
328
35
42
26
2
1
Archives of Medical Research 44:650-54, 2013
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Demonstration ProjectJalisco State
● The objective was to adapt the KEEP methodology to
perform massive and rapid screening of
approximately 10,000 subjects with diabetes
● Collaboration between the Mexican Kidney
Foundation and the Federal and Jalisco State
Secretariat of Health
● Financed by the Popular Insurance of the Secretariat
of Health
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Serum Creatinine Measurement
Challenges
● Most Mexican laboratories don’t measure serum
creatinine by methods traceable to IDMS
● There are significant differences in quality among
laboratories
● Use of a central lab would be expensive and
logistically complicated
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Early Detection of CKD
Epidemiology of CKD in Mexico & CKD prevention
Kidney Early Evaluation (KEEP) Mexico Program
Validation of PoCT measurement of SCr
PoCT testing of albuminuria
Conclusions
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Point of Care 2011;10:98-101.
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Point of Care Testing (PoCT) of
Serum Creatinine with i-STAT
ADVANTAGES
● Easy to use
♦ Capillary or venous blood
♦ Results in 2-4 minutes
♦ 2-hour training
● Immediate on-site results
facilitate clinical decision
making and logistics of
the program
DISADVANTAGES
● More expensive than to
measure SCr in a
standard lab
● Valididty of SCr
measurement in the
Mexican population?
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Comparison of SCr Mesurement (and eGFR)
by i-STAT and IDMS (N = 257)
Serum Creatinine
mg/dL
CrS withi-STAT
Capillary blood 0.82 ± 0.44
Venous blood 0.88 ± 0.42
CrS with IDMS 0.79 ± 0.39
Serum Creatinine
mg/dL
eGFR
(mL/min/1.73 m2)
CrS with i-STAT
Calibrated capillary 0.79 ± 0.37 94.00 ± 24.62
Calibrated venous 0.79 ± 0.36 93.90 ± 24.41
CrS with IDMS 0.79 ± 0.39 94.70 ± 25.54
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Pearson Correlation Calibrated i-STAT SCr and IDMS SCr
Correlation P
0.93 <0.0001
Correlation P
0.90 <0.0001
Capilary blood Venous blood
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SCr-IDMS
SCr i-STAT
0 1 2 3 4 Total
0 154 0 0 0 0 154
1 0 53 5 0 0 58
2 0 4 13 3 0 20
3 1 0 3 15 2 21
4 0 0 0 0 4 4
Total 155 57 21 18 6 257
Comparison of CKD Stagesi-STAT SCr (Capillary) versus IDMS SCr
Gamma Coefficient = 0.99, p < 0.0001
Kappa = 0.88, p < 0.0001
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Sensitivity, Specificity, PPV, NPV
for SCr-iSTAT (Capillary Blood)
Cases
(CKD1-5)
No
cases
Total
Positive 102 1 103
Negative 0 154 154
Total 102 155 257
Valor
Sensitivity 100%
Specificity 99%
PPV 99%
NPV 100%
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Demonstration ProjectJalisco State
Inauguration
Education Training
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Probable CKD Prevalence
44%
22%
13%
8%
1%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Total CKD 1 CKD 1 CKD 3 CKD 4-5
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Probable CKD Prevalence
by Risk Factor
40%
47%
36%
38%
40%
42%
44%
46%
48%
Diabetes DM & HTN
CK
D P
revale
nc
e
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Early Detection of CKD
Epidemiology of CKD in Mexico & CKD
prevention
Kidney Early Evaluation (KEEP) Mexico Program
Validation of PoCT measurement of SCr
PoCT testing of albuminuria
Conclusions
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Pacientes con datos para obtener
tamizaje de ERC
2008 2009 2010 2011 2012 2013
Ambas mediciones(proteinuria/TFG)
71 77,7 78,7 78,3 81 74,6
EGO + TFG 70 77,4 78,3 77,7 78,3 74
Microalbuminuria + TFG 14,8 15,3 10,6 12,6 22,6 16,5
0
10
20
30
40
50
60
70
80
90
%
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Meta-analysis of PoC Tests
to Detect Albuminuria
McTaggart et al. Diagnostic accuracy of point-of-care tests for detecting albuminuria.
A systematic review and meta-analysis. Ann Intern Med 160:550-57, 2014.
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Comparison of PoC Tests
for Detecting Albuminuria
ClinitekStatus
1st morningurine sample
Random urine sample
DCA1st morningurine sample
24-hour
urine
albumin
• Adult pts
with DM
• HCSAE
PEMEX
• Exclusion
of possible
false +
• Sample
size ~ 150 Urinalysis
Micraltest
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ResultsPatient Characteristics (N = 121)
Mean age (years) 65 (34-88)
Female (%) 68%
Mean duration of diabetes (years) 10.2
Hypertension (%) 58%
Mean duration of hypertension (years) 14
Overweight & obesity (%) 44% / 39%
Hypercholesterolemia (%) 56%
Mean duration of hyperlipidemia (years) 6.3
Previous CKD diagnosis 3%
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Results
Clinitek Status DCA
Random urine 1st morning urine 1st morning urine
Sensitivity 76% 76% 81%
Specificity 79% 89% * 99%
PPV 43% 59% 94%
NPV 94% 94% 96%
RV+ 2.3 6.9 81
RV- 0.14 0.27 0.19
Accuracy 79% 87% 96%
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ROC & Area Under the Curve
TestArea under
the curve
DCA 0.90
Clinitek
1st morning
urine0.82
Clinitek
Random
urine0.77
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Results
Clinitek Status DCAMicral Test
(cutoff<20)
Micral Test
(cutoff>20)
Orina al
azar
1a de la
mañana
1a de la
mañana
1st morning
urine
1st morning
urine
Sensitivity 78% 78% 78% 61% 91%
Specificity 80% 89% 100% 97% 65%
False + 20% 11% 0% 3% 35%
False - 22% 22% 22% 39% 9%
PPV 47% 62% 100% 82% 38%
VPN 94% 95% 95% 79% 97%
LR + 3.9 7.1 ∞ 20.3 2.6
LR - 0.27 0.25 0.22 0.40 0.40
Accuracy 80% 87% 96% 90% 70%
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Decision Tree
45,000 tests
52,000 tests
90,000 tests
15,000
22,000
30,000
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Early Detection of CKD
Epidemiology of CKD in Mexico & CKD prevention
Kidney Early Evaluation (KEEP) Mexico Program
Validation of PoCT measurement of SCr
PoCT testing of albuminuria
Conclusions
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Conclusiones
● CKD is frequent and is associated with high
morbidity, mortality and cost
● High prevalence of risk factors for CKD in Mexico
● KEEP Mexico is an effective CKD screening program
● PoC tests for measuring SCr and for detecting
albuminuria are useful in CKD screening programs
● Further studies are needed to determine the best
CKD screening strategies