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

NCT06405100 Phase 3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Air Force Military Medical University, China
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	81
Start date	2024-05
Completion	2027-04

Conditions

• Minimal Change Disease

Interventions

• Supportive care+Prednisone
• Supportive care+Tacrolimus+Ripertamab
• Supportive care+Ripertamab

Primary outcomes

• Relapse rate at 24 months — Up to 24 months after enrollment
  Relapse: Proteinuria\>3.5g/d or PCR\>3500mg/g after complete remission has been achieved.