Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorNanfang Hospital, Southern Medical University

About this trial

The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.

Eligibility criteria

Qualifiers

Children aged 3-18 years old, regardless of sex;

SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria;

Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);

White blood cell count ≥3.0×10^9/L, and lymphocyte count ≥ 0.5× 10^9/L and CD20 (or CD19)≥1/ul;

Disqualifiers

Patients with lupus encephalopathy;

Estimated GFR<60ml/min/1.73m²(Swchartz formula);

HBV-antigen positive, HCV or HIV antibody positive;

Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;

Trial design

Treatments tested in this trial

  • rituximab
  • Mycophenolate Mofetil (MMF) Treatment
  • Cyclophosphamide
  • ACEI / ARB
  • Corticosteroid
  • Hydroxychloroquine (HCQ)

Treatment groups

112 Participants
are divided into 2 treatment groups

Locations

This trial has no locations