| Trial name or title | Ofatumumab in children with steroid‐ and calcineurin‐inhibitor‐resistant nephrotic syndrome: a double‐blind randomised, controlled, superiority trial |
| Methods | RCT |
| Participants | Children aged 2 to 18 years with SRNS (MCD, MesPGN or FSGS) and resistance to CNI and MMF |
| Interventions | Single dose of IV Ofatumumab in normal saline versus placebo (normal saline alone); other immunosuppressive therapies will be withdrawn; all children with receive an ACEi |
| Outcomes | Complete or partial disease remission; adverse events |
| Starting date | March 2015; estimated enrolment 50 children |
| Contact information | Dr Gian Marco Ghiggeri, Istituto Giannina Gaslini, Italy (gmarcoghiggeri@ospedale‐gaslini.ge.it) |
| Notes | Estimated study completion date March 2018 |
ACEi ‐ angiotensin converting enzyme inhibitors; ARB ‐ angiotensin receptor blocker; CNI ‐ calcineurin inhibitor; FSGS ‐ focal segmental glomerulosclerosis; MCD ‐ minimal change disease; MesPGN ‐ mesangioproliferative glomerulonephritis; MMF ‐ mycophenolate mofetil