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NOT YET RECRUITING
NCT06405100
PHASE3

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

Sponsor: Air Force Military Medical University, China

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.

Official title: Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2024-05

Completion Date

2027-04

Last Updated

2024-05-08

Healthy Volunteers

No

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.