Kidney international reports · 2026
Combining Cystatin C and Creatinine Increases eGFR Slope Accuracy in ADPKD.
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Bais Thomas, Mohamed Abdulfataah A A, Noruzi A, Umar Muhammad, Binoy Bella A, Salih M, Meijer Esther, Gansevoort Ron T
Аннотация
INTRODUCTION: In autosomal dominant polycystic kidney disease (ADPKD) trials, creatinine-based estimated glomerular filtration rate (GFR, eGFRcr) is a key end point; however, variability in creatinine measurements may affect reliability. We compared routine eGFRcr to eGFR derived from batch-measured creatinine, cystatin C (eGFRcys), or both (eGFRcr-cys) using biobanked samples, against iothalamate-measured GFR (mGFR).
METHODS: In the 260 patients with ADPKD from the DIPAK observational cohort, we compared 2021 Chronic Kidney Disease (CKD)-Epidemiology Collaboration (CKD-EPI)-based eGFR based on the following: (i) routine clinical creatinine, (ii) batch-measured creatinine, and (iii) batch-measured cystatin C to mGFR. Creatinine and cystatin batch measurements were performed on the same day to minimize variability. Cross-sectional performance was evaluated by bias (eGFR - mGFR), precision, accuracy (P30/P10), and CKD stage agreement. Longitudinal agreement between mGFR and eGFR slopes (ml/min per 1.73 m2/yr) was assessed using concordance correlation coefficients (CCC). Sample size requirements for hypothetical trials were calculated based on slope variability.
RESULTS: Cross-sectional performance of batch-measured eGFRcr was largely similar to routine eGFRcr. eGFRcys and eGFRcr-cys showed greater bias than eGFRcr; eGFRcr-cys showed the highest precision. Longitudinally, batch-measured eGFRcr-cys slopes correlated more strongly with mGFR decline than eGFRcr (CCC: 0.68; 95% confidence interval [CI]: 0.59-0.76] vs. 0.58 [95% CI: 0.47-0.67]; P = 0.02). eGFRcr-cys slopes exhibited lower SDs than eGFRcr and eGFRcys. This reduction in slope variability translated to sample size reductions of 37% to 38% for clinical trials.
CONCLUSION: The use of eGFRcr-cys enhances precision and reduces eGFR slope variability. Using combined creatinine-cystatin C estimates may optimize trial efficiency and design in ADPKD.
METHODS: In the 260 patients with ADPKD from the DIPAK observational cohort, we compared 2021 Chronic Kidney Disease (CKD)-Epidemiology Collaboration (CKD-EPI)-based eGFR based on the following: (i) routine clinical creatinine, (ii) batch-measured creatinine, and (iii) batch-measured cystatin C to mGFR. Creatinine and cystatin batch measurements were performed on the same day to minimize variability. Cross-sectional performance was evaluated by bias (eGFR - mGFR), precision, accuracy (P30/P10), and CKD stage agreement. Longitudinal agreement between mGFR and eGFR slopes (ml/min per 1.73 m2/yr) was assessed using concordance correlation coefficients (CCC). Sample size requirements for hypothetical trials were calculated based on slope variability.
RESULTS: Cross-sectional performance of batch-measured eGFRcr was largely similar to routine eGFRcr. eGFRcys and eGFRcr-cys showed greater bias than eGFRcr; eGFRcr-cys showed the highest precision. Longitudinally, batch-measured eGFRcr-cys slopes correlated more strongly with mGFR decline than eGFRcr (CCC: 0.68; 95% confidence interval [CI]: 0.59-0.76] vs. 0.58 [95% CI: 0.47-0.67]; P = 0.02). eGFRcr-cys slopes exhibited lower SDs than eGFRcr and eGFRcys. This reduction in slope variability translated to sample size reductions of 37% to 38% for clinical trials.
CONCLUSION: The use of eGFRcr-cys enhances precision and reduces eGFR slope variability. Using combined creatinine-cystatin C estimates may optimize trial efficiency and design in ADPKD.