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

Lupus Nephritis Clinical Trial

— MyCITS  

Official title:

Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Therapy of Pediatric Patients With Active Proliferative Lupus Nephritis: A Prospective, Randomized, Multicenter, Open-label, Parallel-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495893
• Other study ID #: 2021YFC2702004
• Status: Recruiting
• Phase: Phase 4
• Start date: July 25, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: Xiaochuan Wu
• Phone: 0731-85295259
• Email: 503151[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cyclophosphamide
• Lupus Nephritis
• Mycophenolate Mofetil
• Nephritis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	the Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (10)

Lead Sponsor

Collaborator

Second Xiangya Hospital of Central South University

Beijing Children's Hospital, Children's Hospital of Chongqing Medical University, Jiangxi Province Children's Hospital, Peking Union Medical College Hospital, Shenzhen Children's Hospital, The Affiliated Hospital of Qingdao University, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate of LN treatment	complete remission and partial remission	6 months
Secondary	complete remission time	complete remission time within 6 months of designed induction therapy	6 months
Secondary	Incidence of LN treatment failure	occurrence of end stage renal disease or serum creatinine reached twice the baseline or 24 urinary protein or urinary protein / creatinine reached twice the baseline at 6 months of follow-up.	6 months
Secondary	Incidence of creatinine doubling	serum creatinine reaching 2 times of the baseline level	6 months
Secondary	LN recurrence rate	(1) proteinuria recurrence, which is defined as continuous proteinuria = 1.0 g/d (or 25mg/kg) after complete remission (CR) or increase = 2.0 g/d (or 50mg/d) after partial remission (PR), with or without hematuria; (2) The increase of Scr level is defined as the increase of Scr level = 50% when the baseline examination is normal, or 30% when the baseline examination is abnormal.	6 months
Secondary	SLE recurrence rate	new onset of skin erythema, vasculitis, joint pain, hematological diseases (platelet <50*109/l or hemolytic anemia), neurological symptoms, lupus myocarditis, lupus pneumonia, serous cavity inflammation or new abnormalities in laboratory examination (antibodies, C3 and C4), and SLEDAI score greater than or equal to 4 points.	6 months
Secondary	SLE disease activity score	Systemic Lupus Erythematosus Disease Activity Index 2000 score at 6 months	6 months
Secondary	partial remission time	Partial remission time within 6 months of designed	6 months