Fact CheckerSign in

NCT07675291Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
112 (estimated)
First submitted
6 May 2026
Start date
Jun 2026
Primary completion date
31 Dec 2028
Lead sponsor
Nanfang Hospital, Southern Medical University
Diseases
Lupus (SLE)
NCT number
NCT07675291

What you commit to

  • Study type: Interventional
  • Planned participants: 112
  • From Jun 2026 to the primary completion date, 31 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Lab values

  • Estimated GFR\<60ml/min/1.73m\^2(Swchartz formula);

Other

  • Patients with lupus encephalopathy;
  • Patients who is not suitable to participate in this study judged by the researchers.

Who the study is looking for

  • 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).

Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.