Lupus NephritisNCT07675291
Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children
A study testing rituximab, Mycophenolate Mofetil (MMF) Treatment and Cyclophosphamide in people with Lupus Nephritis, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- rituximab, Mycophenolate Mofetil (MMF) Treatment and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of 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.
- Conditions
- Lupus Nephritis
- Being tested
- rituximab, Mycophenolate Mofetil (MMF) Treatment, Cyclophosphamide, ACEI / ARB, Corticosteroid
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Rituximab is given monthly (375m/m2；maximum 500mg) for 6 doses
Mycophenolate Mofetil (MMF) TreatmentDrug
The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months.
CyclophosphamideDrug
The therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses.
ACEI / ARBDrug
ACEI/ARB is recommended as the basic therapy for lupus nephritis.
CorticosteroidDrug
Corticosteroid is recommended as the basic therapy for lupus nephritis.
Hydroxychloroquine (HCQ)Drug
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab combining with low-dose mycophenolate mofetil | Experimental | Not described Receives: Drug: rituximab; Drug: Mycophenolate Mofetil (MMF) Treatment; Drug: ACEI / ARB; Drug: Corticosteroid; Drug: Hydroxychloroquine (HCQ) |
| cyclophosphamide | Active comparator | Not described Receives: Drug: Cyclophosphamide; Drug: ACEI / ARB; Drug: Corticosteroid; Drug: Hydroxychloroquine (HCQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）
Measured: 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）.
Measured: 6 months after the intervention
No kidney response
No kidney response is defined as failure to achieve partial or complete response.
Measured: 6 months after the intervention
Secondary outcomes (1)
SLEDAI scores
SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index（SLEDAI）2000.
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675291
- Sponsor's protocol ID
- NEFC-2025-711
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children
- ClinicalTrials.gov ID
- NCT07675291
- Acronym / sponsor ID
- NEFC-2025-711
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab combining with low-dose mycophenolate mofetil | Experimental | Drug: rituximab, Drug: Mycophenolate Mofetil (MMF) Treatment, Drug: ACEI / ARB, Drug: Corticosteroid, Drug: Hydroxychloroquine (HCQ) |
| cyclophosphamide | Active comparator | Drug: Cyclophosphamide, Drug: ACEI / ARB, Drug: Corticosteroid, Drug: Hydroxychloroquine (HCQ) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabRituximab is given monthly (375m/m2；maximum 500mg) for 6 doses | Drug | Rituximab combining with low-dose mycophenolate mofetil |
| Mycophenolate Mofetil (MMF) TreatmentThe dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months. | Drug | Rituximab combining with low-dose mycophenolate mofetil |
| CyclophosphamideThe therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses. | Drug | cyclophosphamide |
| ACEI / ARBACEI/ARB is recommended as the basic therapy for lupus nephritis. | Drug | Rituximab combining with low-dose mycophenolate mofetil, cyclophosphamide |
| CorticosteroidCorticosteroid is recommended as the basic therapy for lupus nephritis. | Drug | Rituximab combining with low-dose mycophenolate mofetil, cyclophosphamide |
| Hydroxychloroquine (HCQ)Hydroxychloroquine is recommended as the basic therapy for lupus nephritis. | Drug | Rituximab combining with low-dose mycophenolate mofetil, cyclophosphamide |
Primary outcome
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）
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）.
No kidney response
Time frame: 6 months after the intervention
No kidney response is defined as failure to achieve partial or complete response.
1 secondary outcome
SLEDAI scores
Time frame: 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing rituximab, Mycophenolate Mofetil (MMF) Treatment and Cyclophosphamide in people with Lupus Nephritis, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liangzhong Sun (+8613316202736, sunlzh2018@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: 6 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.