Clinical trials treating focal segmental glomerulosclerosis should measure patient quality of life

被引：55

作者：

Gipson, Debbie S. ^{[1
]}

Trachtman, Howard ^{[2
]}

Kaskel, Frederick J. ^{[3
]}

Radeva, Milena K. ^{[4
]}

Gassman, Jennifer ^{[4
]}

Greene, Tom H. ^{[5
]}

Moxey-Mims, Marva M. ^{[6
]}

Hogg, Ronald J. ^{[7
]}

Watkins, Sandra L. ^{[8
]}

Fine, Richard N. ^{[9
]}

Middleton, John P. ^{[10
]}

Vehaskari, V. M. ^{[11
,12
,13
]}

Hogan, Susan L. ^{[14
]}

Vento, Suzzane ^{[2
]}

Flynn, Patti A. ^{[3
]}

Powell, Leslie M. ^{[14
]}

McMahan, June L. ^{[4
]}

Siegel, Norman

Friedman, Aaron L. ^{[15
]}

机构：

[1] Univ Michigan, Ann Arbor, MI 48109 USA

[2] Cohen Childrens Hosp, Dept Pediat, Div Nephrol, New York, NY USA

[3] Childrens Hosp, Montefiore Med Ctr, New York, NY USA

[4] Cleveland Clin, Dept Quantitat Hlth Sci, Cleveland, OH 44106 USA

[5] Univ Utah, Div Epidemiol, Salt Lake City, UT USA

[6] NIDDK, NIH, Div Kidney Urol & Hematol, Bethesda, MD USA

[7] Childrens Hosp, Scott & White Med Ctr, Dept Pediat, Temple, TX USA

[8] Univ Washington, Dept Pediat, Div Nephrol, Seattle, WA 98195 USA

[9] SUNY Stony Brook, Sch Med, Med Ctr, Stony Brook, NY 11794 USA

[10] Duke Univ, Dept Med, Div Nephrol, Durham, NC USA

[11] Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA

[12] Childrens Hosp, Res Inst Children, New Orleans, LA USA

[13] LSU Hlth Sci Ctr, New Orleans, LA USA

[14] Univ N Carolina, UNC Kidney Ctr, Div Nephrol & Hypertens Chapel Hill, Chapel Hill, NC USA

[15] Univ Minnesota, Dept Pediat, Minneapolis, MN 55455 USA

来源：

KIDNEY INTERNATIONAL | 2011年 / 79卷 / 06期

关键词：

focal segmental glomerulosclerosis; proteinuria; quality of life; randomized controlled trial; CHRONIC KIDNEY-DISEASE; NEPHROTIC SYNDROME; MYCOPHENOLATE-MOFETIL; SERUM CREATININE; HEALTH-STATUS; CHILDREN; DIALYSIS; OUTCOMES; THERAPY; ADULTS;

D O I：

10.1038/ki.2010.485

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

100201 [内科学]; 100221 [泌尿外科学];

摘要：

Optimal therapy of patients with steroid-resistant primary focal segmental glomerulosclerosis (FSGS) remains controversial. This report describes the initial study design, baseline characteristics, and quality of life of patients enrolled in the FSGS Clinical Trial, a large multicenter randomized study of this glomerulopathy comparing a 12-month regimen of cyclosporine to the combination of mycophenolate mofetil and oral dexamethasone. Patients with age ranging 2-40 years, with an estimated glomerular filtration rate >40 ml/min per 1.73 m(2), a first morning urine protein-to-creatinine ratio over one, and resistant to corticosteroids were eligible. The primary outcome was complete or partial remission of proteinuria over 52 weeks after randomization. In all, 192 patients were screened, of whom 138 were randomized for treatment. Ethnic distributions were 53 black, 78 white, and 7 other. By self-or parent-proxy reporting, 26 of the 138 patients were identified as Hispanic. The baseline glomerular filtration rate was 112.4 (76.5, 180.0) ml/min per 1.73 m(2), and urine protein was 4.0 (2.1, 5.3) g/g. Overall, the quality of life of the patients with FSGS was lower than healthy controls and similar to that of patients with end-stage renal disease. Thus, the impact of FSGS on quality of life is significant and this measurement should be included in all trials. Kidney International (2011) 79, 678-685; doi: 10.1038/ki.2010.485; published online 22 December 2010

引用

页码：678 / 685

页数：8

共 39 条

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Predictive factors of chronic kidney disease in primary focal segmental glomerulosclerosis [J].