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

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

Study Contact Backup

Study Locations

    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:

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:

  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.

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.

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

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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