MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN

NCT ID: NCT05495893

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2025-05-31

Brief Summary

A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population

Detailed Description

Scattered research in adults showed that both mycophenolate mofetil (MMF) and cyclophosphamide (CYC) can be used in the induction therapy of lupus nephritis. however data is limited in children.Therefore, the purpose of this study is to observe and compare the efficacy and safety of MMF and CYC as induction therapy for children with proliferative lupus nephritis through a multi-center open randomized controlled study.

Conditions

Mycophenolate Mofetil; Cyclophosphamide; Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclophosphamide

Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

The patients will be divided into two groups randomly. Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Mycophenolate mofetil

Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

The patients will be divided into two groups randomly. Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Interventions

Cyclophosphamide

The patients will be divided into two groups randomly. Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Intervention Type: DRUG

Mycophenolate Mofetil

The patients will be divided into two groups randomly. Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Only those who fully meet the following criteria can be considered for inclusion in this study:

1. Age 5-17 years old;

2. SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;

3. According to the revised International Society of Nephrology / Society of renal pathology (isn/rps) classification in 2018, it conforms to active proliferative ln type III or IV, with or without type V;

4. Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;

5. 24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;

6. Blood routine WBC count ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/l before enrollment;

7. No immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine A, tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab, baileyoumab, and etaxel were used before enrollment.

Exclusion Criteria

1. A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;

2. Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;

3. Have any history of tumor or cancer;

4. Patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic anemia, blood routine platelet count lower than 10.0*10^9/l, glomerular filtration rate eGFR < 60 ml/min/1.73 m2, or patients with other serious complications have unstable vital signs;

5. Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;

6. Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;

7. Patients who participated in other clinical trials within 3 months before enrollment;

8. The researcher judged that the patient's condition was not suitable for participants in this trial.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Province Children's Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Xiaochuan Wu

Director of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaochuan Wu

Role: STUDY_CHAIR

The Second Xiangya Hospital, Central South University

Locations

the Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaochuan Wu

Role: CONTACT

503151@csu.edu.cn

0731-85295259

Xiaoyan Li

Role: CONTACT

lixiaoyan001@csu.edu.cn

0731-85295259

Facility Contacts

Xiaochuan Wu

Role: primary

503151@csu.edu.cn

073185295259

Other Identifiers

2021YFC2702004

Identifier Type: -

Identifier Source: org_study_id