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Clinical trial of focal segmental glomerulosclerosis in children and young adults.

Abstract：

:This NIH-funded multicenter randomized study of focal segmental glomerulosclerosis (FSGS) treatment compared the efficacy of a 12-month course of cyclosporine to a combination of oral pulse dexamethasone and mycophenolate mofetil in children and adults with steroid-resistant primary FSGS. Of the 192 patients enrolled, 138 were randomized to cyclosporine (72) or to mycophenolate/dexamethasone (66). The primary analysis compared the levels of an ordinal variable measuring remission during the first year. The odds ratio (0.59) for achieving at least a partial remission with mycophenolate/dexamethasone compared to cyclosporine was not significant. Partial or complete remission was achieved in 22 mycophenolate/dexamethasone- and 33 cyclosporine-treated patients at 12 months. The main secondary outcome, preservation of remission for 26 weeks following cessation of treatment, was not significantly different between these two therapies. During the entire 78 weeks of study, 8 patients treated with cyclosporine and 7 with mycophenolate/dexamethasone died or developed kidney failure. Thus, our study did not find a difference in rates of proteinuria remission following 12 months of cyclosporine compared to mycophenolate/dexamethasone in patients with steroid-resistant FSGS. However, the small sample size might have prevented detection of a moderate treatment effect.

journal_name

Kidney Int

journal_title

Kidney international

authors

Gipson DS,Trachtman H,Kaskel FJ,Greene TH,Radeva MK,Gassman JJ,Moxey-Mims MM,Hogg RJ,Watkins SL,Fine RN,Hogan SL,Middleton JP,Vehaskari VM,Flynn PA,Powell LM,Vento SM,McMahan JL,Siegel N,D'Agati VD,Friedman AL

doi

10.1038/ki.2011.195

subject

Has Abstract

pub_date

2011-10-01 00:00:00

pages

868-78

issue

8

eissn

0085-2538

issn

1523-1755

pii

S0085-2538(15)55138-7

journal_volume

80

pub_type

杂志文章,多中心研究,随机对照试验

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