- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05495893
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN (MyCITS)
August 8, 2022 updated by: Xiaochuan Wu, Second Xiangya Hospital of Central South University
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
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
224
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaochuan Wu
- Phone Number: 0731-85295259
- Email: 503151@csu.edu.cn
Study Contact Backup
- Name: Xiaoyan Li
- Phone Number: 0731-85295259
- Email: lixiaoyan001@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Recruiting
- The Second Xiangya Hospital of Central South University
-
Contact:
- Xiaochuan Wu
- Phone Number: 073185295259
- Email: 503151@csu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective rate of LN treatment
Time Frame: 6 months
|
complete remission and partial remission
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete remission time
Time Frame: 6 months
|
complete remission time within 6 months of designed induction therapy
|
6 months
|
Incidence of LN treatment failure
Time Frame: 6 months
|
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
|
Incidence of creatinine doubling
Time Frame: 6 months
|
serum creatinine reaching 2 times of the baseline level
|
6 months
|
LN recurrence rate
Time Frame: 6 months
|
(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
|
SLE recurrence rate
Time Frame: 6 months
|
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
|
SLE disease activity score
Time Frame: 6 months
|
Systemic Lupus Erythematosus Disease Activity Index 2000 score at 6 months
|
6 months
|
partial remission time
Time Frame: 6 months
|
Partial remission time within 6 months of designed
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Xiaochuan Wu, the Second Xiangya Hospital, Central South University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2022
Primary Completion (Anticipated)
May 31, 2025
Study Completion (Anticipated)
May 31, 2025
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
August 8, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cyclophosphamide
- Mycophenolic Acid
Other Study ID Numbers
- 2021YFC2702004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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