Proteinuria has been established as a marker of kidney damage in experimental studies and clinicians consider an early reduction in albuminuria as indicative of a favorable response to treatment. Albuminuria is a sensitive marker of kidney disease progression in early stages of CKD and appears to be a cause of CKD progression in some disease. Our initial publication in the general CKD population did not provide sufficient evidence to establish its validity in all settings. Indeed in a subsequently publication in IgA nephropathy, we were able to demonstrate that there is strong association between treatment effects on change in albuminuria and treatment effects on the clinical endpoint. In a subsequent larger meta-analysis in the general CKD population, we were able to provide data that support a role for change in albuminuria as a surrogate endpoint for CKD progression, particularly in patients with higher baseline albuminuria and where there are large treatment effects.
- Inker, L.A., Levey, A.S., Pandya, K., Stoycheff, N., Okparavero, A., Greene, T. and Chronic Kidney Disease Epidemiology Collaboration, 2014. Early change in proteinuria as a surrogate end point for kidney disease progression: an individual patient meta-analysis. American Journal of Kidney Diseases, 64(1), pp.74-85. PMID: 24787763 PMCID: PMC4070618
- Inker, LA, Mondal, H, Greene, T, Masaschi, T, Locatelli, F, Schena, FP, Katafuchi, R, Appel, GB, Maes, BD, Li, PK and Praga, M, 2016. Early change in urine protein as a surrogate end point in studies of IgA nephropathy: an individual-patient meta-analysis. American Journal of Kidney Diseases, 68(3), pp.392-401. PMID: 27032886
- Heerspink, H.J., Greene, T., Tighiouart, H., Gansevoort, R.T., Coresh, J., Simon, A.L., Chan, T.M., Hou, F.F., Lewis, J.B., Locatelli, F. and Praga, M., 2019. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. The Lancet Diabetes & Endocrinology, 7(2), pp.128-139. PMID: 30635226
- Coresh, J., Heerspink, H.J., Sang, Y., Matsushita, K., Arnlov, J., Astor, B.C., Black, C., Brunskill, N.J., Carrero, J.J., Feldman, H.I. and Fox, C.S., 2019. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies. The Lancet Diabetes & Endocrinology, 7(2), pp.115-127. PMID: 30635225 PMCID: PMC6379893 [Available on 2020-02-01]
- Thompson, A., Carroll, K., Inker, L.A., Floege, J., Perkovic, V., Boyer-Suavet, S., Major, R.W., Schimpf, J.I., Barratt, J., Cattran, D.C. and Gillespie, B.S., 2019. Proteinuria reduction as a surrogate end point in trials of IgA nephropathy. Clinical Journal of the American Society of Nephrology, 14(3), pp.469-481. PMID: 30635299 PMCID: PMC6419287 [Available on 2020-03-07]