Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration. Export

@article{citeulike:5223414, abstract = {Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States. We discuss surrogate end points in clinical trials of drug therapy, including criteria for drug approval, the definition of a surrogate end point, and criteria for evaluation of surrogacy based on biological plausibility, epidemiological characteristics, and clinical trials. Next, the report summarizes data for proteinuria as a potential surrogate outcome in 3 broad clinical areas: early diabetic kidney disease, nephrotic syndrome, and diseases with mild to moderate proteinuria. We conclude with a synthesis of data and recommendations for further research. At the present time, there appears to be sufficient evidence to recommend changes in proteinuria as a surrogate for kidney disease progression in only selected circumstances. Further research is needed to define additional contexts in which changes in proteinuria can be expected to predict treatment effect. We recommend collaboration among many groups, including academia, industry, the FDA, and the National Institutes of Health, to share data from past and future studies.}, author = {Levey, Andrew S. and Cattran, Daniel and Friedman, Aaron and Miller, W. Greg and Sedor, John and Tuttle, Katherine and Kasiske, Bertram and Hostetter, Thomas}, citeulike-article-id = {5223414}, citeulike-linkout-0 = {http://dx.doi.org/10.1053/j.ajkd.2009.04.029}, citeulike-linkout-1 = {http://linkinghub.elsevier.com/retrieve/pii/S027263860900763X}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/19577347}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=19577347}, doi = {10.1053/j.ajkd.2009.04.029}, issn = {1523-6838}, journal = {American journal of kidney diseases : the official journal of the National Kidney Foundation}, keywords = {ckd, proteinuria, surrogate}, month = {August}, number = {2}, pages = {205--226}, posted-at = {2009-07-22 03:06:38}, priority = {2}, title = {Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.}, url = {http://dx.doi.org/10.1053/j.ajkd.2009.04.029}, volume = {54}, year = {2009} }

TY - JOUR ID - citeulike:5223414 L3 - citeulike-article-id:5223414 N2 - Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States. We discuss surrogate end points in clinical trials of drug therapy, including criteria for drug approval, the definition of a surrogate end point, and criteria for evaluation of surrogacy based on biological plausibility, epidemiological characteristics, and clinical trials. Next, the report summarizes data for proteinuria as a potential surrogate outcome in 3 broad clinical areas: early diabetic kidney disease, nephrotic syndrome, and diseases with mild to moderate proteinuria. We conclude with a synthesis of data and recommendations for further research. At the present time, there appears to be sufficient evidence to recommend changes in proteinuria as a surrogate for kidney disease progression in only selected circumstances. Further research is needed to define additional contexts in which changes in proteinuria can be expected to predict treatment effect. We recommend collaboration among many groups, including academia, industry, the FDA, and the National Institutes of Health, to share data from past and future studies. IS - 2 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation SN - 1523-6838 EP - 226 TI - Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration. VL - 54 SP - 205 KW - ckd KW - proteinuria KW - surrogate AU - Levey, Andrew AU - Cattran, Daniel AU - Friedman, Aaron AU - Miller, Greg AU - Sedor, John AU - Tuttle, Katherine AU - Kasiske, Bertram AU - Hostetter, Thomas PY - 2009/08// UR - http://dx.doi.org/10.1053/j.ajkd.2009.04.029 ER -