GFR decline as an end point in trials of CKD: A viewpoint from the FDA

American Journal of Kidney Diseases

Volumn 64, Issue 6, 2014, Pages 836-837

  Thompson, Aliza ^a   Lawrence, John ^a   Stockbridge, Norman ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CAPTOPRIL; CREATININE; IRBESARTAN; LOSARTAN;

CHRONIC KIDNEY DISEASE; CLINICAL TRIAL (TOPIC); CREATININE BLOOD LEVEL; DIABETIC NEPHROPATHY; DIALYSIS; DRUG APPROVAL; EDITORIAL; END STAGE RENAL DISEASE; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; KIDNEY TRANSPLANTATION; BIOASSAY; EDUCATION; NON PROFIT ORGANIZATION; PHYSIOLOGY; RENAL INSUFFICIENCY, CHRONIC; STANDARDS;

EDUCATION; ENDPOINT DETERMINATION; FOUNDATIONS; GLOMERULAR FILTRATION RATE; HUMANS; RENAL INSUFFICIENCY, CHRONIC; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84910607379     PISSN: 02726386     EISSN: 15236838     Source Type: Journal    
DOI: 10.1053/j.ajkd.2014.09.006     Document Type: Editorial

References (6)

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2. L.A. Inker, H.J. Lambers Heerspink, and H. Mondal GFR decline as an alternative end point to kidney failure in clinical trials: a meta-analysis of treatment effects from 37 randomized trials Am J Kidney Dis 64 6 2014 848 859
3. H.J. Lambers Heerspink, H. Tighiouart, and Y. Sang GFR decline and subsequent risk of established kidney outcomes: a meta-analysis of 37 randomized controlled trials Am J Kidney Dis 64 6 2014 860 866
4. T. Greene, C.-C. Teng, and L.A. Inker Utility and validity of estimated GFR-based surrogate time-to-event end points in CKD: a simulation study Am J Kidney Dis 64 6 2014 867 879
5. J. Coresh, T.C. Turin, and K. Matsushita Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality JAMA 311 24 2014 2518 2531
6. R. Haynes, N. Staplin, and J. Emberson Evaluating the contribution of the cause of kidney disease to prognosis in CKD: results from the study of heart and renal protection (SHARP) Am J Kidney Dis 64 1 2014 40 48