Trial name or title | Efficacy and safety of rituximab to that of calcineurin inhibitors in children with steroid resistant nephrotic syndrome |
Methods | Open label RCT |
Participants | Children aged 3 to 16 years with SRNS (MCD, MesPGN or FSGS) |
Interventions | Rituximab infusions weekly for 2 to 4 doses over up to 4 weeks compared with oral tacrolimus given until the child has achieved 6 months of relapse free survival |
Outcomes | 12‐month relapse‐free survival in the ITT population; adverse effects |
Starting date | March 2015; estimated enrolment 120 children |
Contact information | Dr. Biswanath Basu, Nilratan Sircar Medical College, India (basuv3000@gmail.com) |
Notes | Estimated study completion date March 2017 Other study numbers: PednephroRCT/PM/NRSMCH‐33, CTRI/2015/01/005364 |