Health TrialsbyHealthPanel

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

ConditionLupus Nephritis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Rituximab combining with low-dose mycophenolate mofetilExperimental treatment 5 interventions
Group B: cyclophosphamideActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

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）

Time frame
6 months after the intervention
2

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）.

Time frame
6 months after the intervention
3

No kidney response

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

Time frame
6 months after the intervention

Secondary outcomes

1

SLEDAI scores

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

Time frame
6 months after the intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: