Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

May 31, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2027

Conditions
Minimal Change Disease
Interventions
DRUG

Supportive care+Prednisone

"Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.~Induction period: 1mg/kg/day. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks.~Maintenance period: A reduction of 5-10mg/wk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg/day."

DRUG

Supportive care+Tacrolimus+Ripertamab

"Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.~Tacrolimus:Induction period: 0.05mg/kg/d. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng/ml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng/ml, and stopped after 6 months of maintenance treatment.~Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months."

DRUG

Supportive care+Ripertamab

"Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.~Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months."

All Listed Sponsors
collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

collaborator

The Second Affiliated Hospital of Air Force Military Medical University

UNKNOWN

collaborator

Shaanxi Provincial People's Hospital

OTHER

collaborator

Shaanxi Provincial Hospital of Chinese Medicine

UNKNOWN

lead

Air Force Military Medical University, China

OTHER