Ofatumumab versus Rituximab in children with steroid and calcineurin inhibitor-dependent idiopatic nephrotic syndrome: an open-label, randomized, controlled, superiority trial. - Ofatumumab versus Rituximab in treatment of steroid dependent INS

IRCCS ISTITUTO GIANNINA GASLINI0 个研究点目标入组 140 人开始时间: 2020年11月5日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•-To be in complete disease remission
•-Drug dependence: remission has to be maintained with both steroids and CNI
•steroid dependence is defined by two consecutive relapses during corticosteroid therapy or within 14 days of ceasing therapy.
•CNI (cyclosporine/tacrolimus) dependence is defined by presence of relapse at discontinuation.
•-Ability to provide consent and assent: parents’/guardian’s written informed consent, and child’s assent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.
•-Age between 2 and 18 years
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Positivity to autoimmunity tests (ANA, nDNA, ANCA)
•-Reduction of C3 levels.
•-eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
•-Pregnancy
•-Infections: previous or actual HBV (with HBeAb positivity) or HCV infection
•-CD20 B lymphocytes count <2,5%
•-Treatment with Rituximab or cyclophosphamide in the last 6 months
•-Homozygous or heterozygous mutations of podocitary genes, commonly involved in the etiology of INS (NPHS1, NPHS2, NPHS3, NPHS6, WT1, COQ2, COQ6, MYO1E, SMARCAL1, LAMB2, SCARB2, CD2AP, TRPC6, ACTN4, INF2, LMX1B, MYH9 )

发起方

IRCCS ISTITUTO GIANNINA GASLINI