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

Minimal Change Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome. The pathological features of the disease are no or only slight changes under light microscope, and the foot process fusion under electron microscope. The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD. However, 48%-76% of patients relapse after tapering or gradual discontinuation of the drug, requiring a high cumulative dose of glucocorticoids. As the cumulative dose of glucocorticoids increases, the potential for side effects increases. In addition, 10% to 30% of patients frequently relapse, and 15% to 30% of these are steroid dependent. Therefore, the clinical goals for patients with MCD are to achieve early remission of proteinuria, reduce hormonal side effects, and more importantly, prevent the recurrence of proteinuria. ;

Related Conditions & MeSH terms

• Minimal Change Disease
• Nephrosis, Lipoid

• NCT number: NCT06405100
• Study type: Interventional
• Source: Air Force Military Medical University, China
• Contact: shiren Sun[Author], Doctor
• Phone: 18729387675
• Email: 272844142@qq.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Completion date: April 2027