Proteinuria as a surrogate end point-more data are needed

Nature Reviews Nephrology

Volumn 8, Issue 5, 2012, Pages 306-309

  Thompson, Aliza ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIANEMIC AGENT; ANTIHYPERTENSIVE AGENT; CREATININE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENCAINIDE; FLECAINIDE; PLACEBO;

ANTIHYPERTENSIVE THERAPY; BLOOD PRESSURE REGULATION; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY DISEASE; CREATININE BLOOD LEVEL; DATA ANALYSIS; DIABETIC NEPHROPATHY; DISEASE MARKER; DRUG APPROVAL; DRUG EFFICACY; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HEART VENTRICLE EXTRASYSTOLE; HUMAN; HYPERTENSION; MORTALITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROTEINURIA; REVIEW; SIDE EFFECT; STROKE;

BIOLOGICAL MARKERS; DIABETIC NEPHROPATHIES; DISEASE PROGRESSION; ENDPOINT DETERMINATION; HUMANS; KIDNEY FAILURE, CHRONIC; PROTEINURIA;

EID: 84860271774     PISSN: 17595061     EISSN: 1759507X     Source Type: Journal    
DOI: 10.1038/nrneph.2012.43     Document Type: Review

References (18)

1. Levey, A. S. et al. 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. Am. J. Kidney Dis. 54, 205-226 (2009).
2. Temple, R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 282, 790-795 (1999). (Pubitemid 29404390)
3. Fleming T. R. & DeMets, D. L. Surrogate end points in clinical trials: are we being misled? Ann. Intern. Med. 125, 605-613 (1996). (Pubitemid 126450094)
4. Prentice, R. L. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 8, 431-440 (1989). (Pubitemid 19105891)
5. Desai, M., Stockbridge, N. & Temple, R. Blood pressure as an example of a biomarker that functions as a surrogate. AAPS J. 8, E146-E152 (2006).
6. Foley, R. N. et al. The impact of anemia on cardiomyopathy, morbidity, and and mortality in end-stage renal disease. Am. J. Kidney Dis. 28, 53-61 (1996). (Pubitemid 26231466)
7. Locatelli, F. et al. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol. Dial. Transplant. 19, 121-132 (2004). (Pubitemid 38072623)
8. Besarab, A. et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N. Engl. J. Med. 339, 584-590 (1998). (Pubitemid 28385655)
9. Besarab, A., Goodkin, D. A. & Nissenson, A. R. The normal hematocrit study\follow-up. N. Engl. J. Med. 358, 433-434 (2008).
10. Pfeffer, M. A. et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N. Engl. J. Med. 361, 2019-2032 (2009).
11. Singh, A. K. et al. Correction of anemia with epoetin alfa in chronic kidney disease. N. Engl. J. Med. 355, 2085-2098 (2006). (Pubitemid 44749317)
12. Drugs@FDA: FDA Approved Drug Products. Drug label approved on 24 June 2011 for Aranesp (darbepoetin alpha) [online] http://www.accessdata.fda.gov/ drugsat.fdadocs/label/2011/103951Orig1s5173103951Orig1s5258lbl.pdf (2011).
13. Brenner, B. M. et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N. Engl. J. Med. 345, 861-869 (2001).
14. Lewis, E. J., Hunsicker, L. G., Bain, R. P. & Rohde, R. D. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N. Engl. J. Med. 329, 1456-1462 (1993). (Pubitemid 23335891)
15. Lewis, E. J. et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N. Engl. J. Med. 345, 851-860 (2001).
16. Mann, J. F et al. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet 372, 547-553 (2008).
17. Bakris, G. L. et al. Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of a randomised controlled trial. Lancet 375, 1173-1181 (2010).
18. Temple, R. Enrichment of clinical study populations. Clin. Pharmacol. Ther. 88, 774-778 (2010).