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

PHASE4CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

May 31, 2023

Study Completion Date

July 12, 2023

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."

Trial Locations (12)

100032

Peking University First Hospital, Beijing

201102

Children's Hospital of Fudan University, Shanghai

210008

Nanjing Children's Hospital, Nanjing

215002

Children's Hospital of Soochow University, Suzhou

250021

Shandong Provincial Hospital, Jinan

310006

The Children Hospital of Zhejiang University School of Medicine, Hangzhou

401122

Children's Hospital of Chongqing Medical University, Chongqing

410011

Second Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital, Wuhan

451161

Henan Children's Hospital, Zhengzhou

510080

First Affiliated Hospital of Zhongshan Medical University, Guangzhou

610043

Chengdu Women and Children's Center Hospital, Chengdu

All Listed Sponsors
collaborator

Children's Hospital of Fudan University

OTHER

collaborator

Peking University First Hospital

OTHER

collaborator

First Affiliated Hospital of Zhongshan Medical University

OTHER

collaborator

Nanjing Children's Hospital

OTHER

collaborator

Chengdu Women and Children's Center Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Second Xiangya Hospital of Central South University

OTHER

collaborator

Children's Hospital of Chongqing Medical University

OTHER

collaborator

Children's Hospital of Soochow University

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

lead

The Children's Hospital of Zhejiang University School of Medicine

OTHER

NCT04048161 - Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome | Biotech Hunter | Biotech Hunter