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. 2017 Mar 29;10(2):192–201. doi: 10.1093/ckj/sfx002

Table 1.

List of studies published that support the benefit of CKD273

Study background Study information Number of samples Study type Performance (CKD273) Comparator Performance (comparator) Reference
Diagnosis of DN in T2D patients Diagnosis: macroalbuminuria 137 Cross-sectional

  • Sens. 95%

  • Spec. 89%

  • AUC 0.96

 — — Molin et al. [32]
Prediction of DN in T2D patients Normalbuminuric patients transition to macroalbuminuria 316 (35 patients) Longitudinal

  • 5-year follow-up: AUC 0.93

  • Normalbuminuric samples: AUC 0.92

 UAE

  • 5-year follow-up: AUC 0.86

  • Normalbuminuric samples: AUC 0.67

 Zürbig et al. [37]
Prediction of transition to higher albuminuria stages Transition from normo- to microalbuminuria, transition from micro- to macroalbuminuria 88 Longitudinal

  • AUC 0.94

  • OR 1.35

 eGFR + UAE AUC 0.91 Roscioni et al. [38]
Association with renal hard endpoints

  • Correlation with UAE and eGFR

  • association with death or dialysis after 3.6 years

 53 Longitudinal — UAE — Argiles et al. [39]
Multicentric diagnosis of DN in T2D patients Diagnosis: macroalbuminuria 167 Cross-sectional AUC 0.95–1.00 — — Siwy et al. [40]
Diagnosis and prediction of CKD progression Prognosis: eGFR decline >5% per year

  • 1990

  • 522

 Cross-sectional Longitudinal AUC 0.821 eGFR + UAE AUC 0.758 Schanstra et al. [41]
Diagnosis and risk of progression to CKD Prognosis: eGFR decline >4 mL/min/ 1.73 m2/year 35 Longitudinal

  • AUC 0.98

  • Sens. 95%

  • Spec. 100%

 UAE (dipstick) AUC 0.85 Ovrehus et al. [42]
Prediction of decline in glomerular filtration

  • eGFR strata of 10 mL/min/1.73 m2

  • Prognosis: eGFR decline >5 mL/min/ 1.73 m2/year

 2627 Longitudinal

  • eGFR >80: AUC 0.652

  • eGFR 70–79: AUC 0.700

 UAE

  • eGFR >80: AUC 0.580

  • eGFR 70-79: AUC 0.577

 Pontillo et al. [43]
Post hoc analysis of the DIRECT-Protect 2 trial

  • Normalbuminuric patients

  • RCT with candesartan

  •  endpoint: microalbuminuria

 737 Longitudinal

  • HR 2.65

  • AUC 0.79

  • UAE

  • eGFR

  • HR 2.03

  • HR 1.40

 Lindhardt et al. [44]
Prediction of CKD stage 3 Longitudinal study, prediction of CKD stage 3 2087 Longitudinal HR 1.23

  • UAE

  • eGFR

  • HR 1.06

  • HR 0.71

 Pontillo et al., submitted for publication [52]

DN, ; HR, hazard ratio; T2D, ; Sens., sensitivity; Spec., specificity.