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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Am+Soc+Nephrol
2015 ; 26
(9
): 2259-66
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gab.com Text
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Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter,
Open-Label, Noninferiority, Randomized Controlled Trial
#MMPMID25592855
Ravani P
; Rossi R
; Bonanni A
; Quinn RR
; Sica F
; Bodria M
; Pasini A
; Montini G
; Edefonti A
; Belingheri M
; De Giovanni D
; Barbano G
; Degl'Innocenti L
; Scolari F
; Murer L
; Reiser J
; Fornoni A
; Ghiggeri GM
J Am Soc Nephrol
2015[Sep]; 26
(9
): 2259-66
PMID25592855
show ga
Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from
steroids or steroid-sparing agents. This open-label, noninferiority, randomized
controlled trial at four sites in Italy tested whether rituximab is noninferior
to steroids in maintaining remission in juvenile SDNS. We enrolled children age
1-16 years who had developed SDNS in the previous 6-12 months and were maintained
in remission with high prednisone doses (?0.7 mg/kg per day). We randomly
assigned participants to continue prednisone alone for 1 month (control) or to
add a single intravenous infusion of rituximab (375 mg/m(2); intervention).
Prednisone was tapered in both groups after 1 month. For noninferiority,
rituximab had to permit steroid withdrawal and maintain 3-month proteinuria
(mg/m(2) per day) within a prespecified noninferiority margin of three times the
levels among controls (primary outcome). We followed participants for ?1 year to
compare risk of relapse (secondary outcome). Fifteen children per group (21 boys;
mean age, 7 years [range, 2.6-13.5 years]) were enrolled and followed for ?60
months (median, 22 months). Three-month proteinuria was 42% lower in the
rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to
1.95 [i.e., within the noninferiority margin of three times the levels in
controls]). All but one child in the control group relapsed within 6 months;
median time to relapse in the rituximab group was 18 months (95% confidence
interval, 9 to 32 months). In the rituximab group, nausea and skin rash during
infusion were common; transient acute arthritis occurred in one child. In
conclusion, rituximab was noninferior to steroids for the treatment of juvenile
SDNS.