Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children
Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children
1 other identifier
interventional
112
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 30, 2026
June 1, 2026
2.6 years
May 6, 2026
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Complete response
Patients are defined as having a complete response if they meet all the following conditions: ①Proteinuria is \<0.5 g/1.73m\^2 per day or protein-creatinine ratio from a morning spot urine \<0.2 g/g ②Renal function is stabilized or improved（±10%-15% of baseline）
6 months after the intervention
Partial response
A partial response is defined for patients who do not meet the complete response criteria but satisfy both of the following criteria: ①Urinary protein is reduced by ≥ 50% from baseline, and protein-creatinine ratio from a morning spot urine \< 3.0g/g ②Renal function is stable or improved（±10%-15% of baseline）.
6 months after the intervention
No kidney response
No kidney response is defined as failure to achieve partial or complete response.
6 months after the intervention
Secondary Outcomes (1)
SLEDAI scores
6 months after the intervention
Study Arms (2)
Rituximab combining with low-dose mycophenolate mofetil
EXPERIMENTALcyclophosphamide
ACTIVE COMPARATORInterventions
The therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses.
ACEI/ARB is recommended as the basic therapy for lupus nephritis.
Corticosteroid is recommended as the basic therapy for lupus nephritis.
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.
Rituximab is given monthly (375m/m2；maximum 500mg) for 6 doses
The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months.
Eligibility Criteria
You may qualify if:
- 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;
- No cyclophosphamide or rituximab induction therapy was used before enrollment;
- Informed consent form is signed by the guardian and children over 8 years old;
- In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg;
- Estimated GFR≥60ml/min/1.73m\^2 (improved Swchartz formula).
You may not qualify if:
- Patients with lupus encephalopathy;
- Estimated GFR\<60ml/min/1.73m\^2(Swchartz formula);
- HBV-antigen positive, HCV or HIV antibody positive;
- Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;
- Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;
- Severe heart failure and liver function damage;
- Patients who is not suitable to participate in this study judged by the researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
June 30, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
June 30, 2026
Record last verified: 2026-06