Back to resultsMMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN (MyCITS)
Primary Purpose
Mycophenolate Mofetil, Cyclophosphamide, Lupus Nephritis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cyclophosphamide
Mycophenolate Mofetil
Sponsored by
About this trial
This is an interventional treatment trial for Mycophenolate Mofetil
Eligibility Criteria
Inclusion Criteria:
Only those who fully meet the following criteria can be considered for inclusion in this study:
- Age 5-17 years old;
- SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
- 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;
- Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
- 24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;
- Blood routine WBC count ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/l before enrollment;
- 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:
- A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
- Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
- Have any history of tumor or cancer;
- 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;
- Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;
- Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;
- Patients who participated in other clinical trials within 3 months before enrollment;
- The researcher judged that the patient's condition was not suitable for participants in this trial.
Sites / Locations
- the Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cyclophosphamide
Mycophenolate mofetil
Arm Description
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
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
Outcomes
Primary Outcome Measures
Effective rate of LN treatment
complete remission and partial remission
Secondary Outcome Measures
complete remission time
complete remission time within 6 months of designed induction therapy
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.
Incidence of creatinine doubling
serum creatinine reaching 2 times of the baseline level
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.
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.
SLE disease activity score
Systemic Lupus Erythematosus Disease Activity Index 2000 score at 6 months
partial remission time
Partial remission time within 6 months of designed
Full Information
NCT ID
NCT05495893
First Posted
July 25, 2022
Last Updated
August 8, 2022
Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Peking Union Medical College Hospital, Children's Hospital of Chongqing Medical University, Beijing Children's Hospital, Jiangxi Province Children's Hospital, The Affiliated Hospital of Qingdao University, Shenzhen Children's Hospital, The First Affiliated Hospital of Zhengzhou University, The Children's Hospital of Zhejiang University School of Medicine, The Second Hospital of Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05495893
Brief Title
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Peking Union Medical College Hospital, Children's Hospital of Chongqing Medical University, Beijing Children's Hospital, Jiangxi Province Children's Hospital, The Affiliated Hospital of Qingdao University, Shenzhen Children's Hospital, The First Affiliated Hospital of Zhengzhou University, The Children's Hospital of Zhejiang University School of Medicine, The Second Hospital of Hebei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycophenolate Mofetil, Cyclophosphamide, Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyclophosphamide
Arm Type
Experimental
Arm Description
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
Arm Title
Mycophenolate mofetil
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effective rate of LN treatment
Description
complete remission and partial remission
Time Frame
6 months
Secondary Outcome Measure Information:
Title
complete remission time
Description
complete remission time within 6 months of designed induction therapy
Time Frame
6 months
Title
Incidence of LN treatment failure
Description
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.
Time Frame
6 months
Title
Incidence of creatinine doubling
Description
serum creatinine reaching 2 times of the baseline level
Time Frame
6 months
Title
LN recurrence rate
Description
(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.
Time Frame
6 months
Title
SLE recurrence rate
Description
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.
Time Frame
6 months
Title
SLE disease activity score
Description
Systemic Lupus Erythematosus Disease Activity Index 2000 score at 6 months
Time Frame
6 months
Title
partial remission time
Description
Partial remission time within 6 months of designed
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Only those who fully meet the following criteria can be considered for inclusion in this study:
Age 5-17 years old;
SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
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;
Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;
Blood routine WBC count ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/l before enrollment;
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:
A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
Have any history of tumor or cancer;
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;
Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;
Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;
Patients who participated in other clinical trials within 3 months before enrollment;
The researcher judged that the patient's condition was not suitable for participants in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaochuan Wu
Phone
0731-85295259
Email
503151@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Li
Phone
0731-85295259
Email
lixiaoyan001@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaochuan Wu
Organizational Affiliation
The Second Xiangya Hospital, Central South University
Official's Role
Study Chair
Facility Information:
Facility Name
the Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochuan Wu
Phone
073185295259
Email
503151@csu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
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