Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome

Summary

Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is uesful for primary nephrotic syndrome, proning to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment, and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, randomized, multicenter, open, parallel controlled trial, evaluating the efficacy and safety of steroid combined with the immunosuppressive agents which are tacrolimus and mycophenolate mofetil to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.

Conditions

• Nephrotic Syndrome in Children

Interventions

DRUG

Tacrolimus

The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is \< 5ng/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.

DRUG

Mycophenolate Mofetil

The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20\~30mg/kg/day，BID. The concentration for MPA-AUC is 30\~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.

Sponsors & Collaborators

• Children's Hospital of Fudan University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhongshan Medical University

  collaborator OTHER

• Nanjing Children's Hospital

  collaborator OTHER

• Chengdu Women and Children's Center Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Children's Hospital of Soochow University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

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

  lead OTHER

Principal Investigators

• Jianhua Mao, MD · Children's Hospital, Zhejiang University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-12

Primary Completion

2023-05-31

Completion

2023-07-12

Countries

• China

Study Locations