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NCT Number: NCT07675291

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Rituximab

Drug

Rituximab is given monthly (375m/m2;maximum 500mg) for 6 doses

Mycophenolate Mofetil (MMF) Treatment

Drug

The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months.

Cyclophosphamide

Drug

The therapy for cyclophosphamide is 750mg/m2(maximum 1000mg) every month for 6 doses.

ACEI / ARB

Drug

ACEI/ARB is recommended as the basic therapy for lupus nephritis.

Corticosteroid

Drug

Corticosteroid is recommended as the basic therapy for lupus nephritis.

Hydroxychloroquine (HCQ)

Drug

Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.

Primary outcomes

  1. Complete response

    Time frame: 6 months after the intervention

    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)

  2. Partial response

    Time frame: 6 months after the intervention

    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).

  3. No kidney response

    Time frame: 6 months after the intervention

    No kidney response is defined as failure to achieve partial or complete response.

Secondary outcomes

  1. SLEDAI scores

    Time frame: 6 months after the intervention

    SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)2000.

Study contacts

Contact information is provided by the study sponsor or research team.

Liangzhong Sun

CONTACT

[email protected]

+8613316202736

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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