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

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

Conditions

• Mycophenolate Mofetil
• Cyclophosphamide
• Lupus Nephritis

Interventions

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.

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shenzhen Children's Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• Xiaochuan Wu · The Second Xiangya Hospital, Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-25

Primary Completion

2025-05-31

Completion

2025-05-31

Countries

• China

Study Locations