Validation of the Klinrisk chronic kidney disease progression model in the FIDELITY population
Navdeep Tangri, Thomas Ferguson, Silvia J Leon, Stefan D Anker, Gerasimos Filippatos, Bertram Pitt, Peter Rossing, Luis M Ruilope, Alfredo E Farjat, Youssef M K Farag, Patrick Schloemer, Robert Lawatscheck, Katja Rohwedder, George L Bakris- Transplantation
- Nephrology
Abstract
Background
Chronic kidney disease (CKD) affects > 800 million individuals worldwide and is often under-recognized. Early detection, identification, and treatment can delay disease progression. Klinrisk is a proprietary risk prediction model based on common laboratory data to predict CKD progression. We aimed to externally validate the Klinrisk model for prediction of CKD progression in FIDELITY (a prespecified pooled analysis of two finerenone phase III trials in patients with CKD and type 2 diabetes). In addition, we sought to identify evidence of an interaction between treatment and risk.
Methods
The validation cohort included all participants in FIDELITY up to 4 years. The primary and secondary composite outcomes included a ≥ 40% decline in estimated glomerular filtration rate (eGFR) or kidney failure, and a ≥ 57% decline in eGFR or kidney failure. Prediction discrimination was calculated using area under the receiver operating characteristic curve (AUC). Calibration plots were calculated by decile comparing observed with predicted risk.
Results
At time horizons of 2 and 4 years, 993 and 1795 patients experienced a primary outcome event, respectively. The model predicted the primary outcome accurately with an AUC of 0.81 for 2 years and 0.86 for 4 years. Calibration was appropriate at both 2 and 4 years, with Brier scores of 0.067 and 0.115, respectively. No evidence of interaction between treatment and risk was identified for the primary composite outcome (P = 0.31).
Conclusions
Our findings demonstrate the accuracy and utility of a laboratory-based prediction model for early identification of patients at the highest risk of CKD progression.