Different Immunosuppressive Treatment in iMN

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how effective different immunosuppressive treatments are for patients with idiopathic membranous nephropathy (iMN), a condition that affects the kidneys. The main goal is to see which treatment can help patients achieve remission, meaning their symptoms improve or go away, over a period of 24 months. The trial is currently looking for participants aged 65 to 74 years and those aged 29 to 219 years, regardless of gender.

To be eligible for the trial, participants must have a diagnosis of iMN and meet certain criteria, such as being post-menopausal or using effective contraception if they are female. They should also have been off specific medications like steroids for at least one month and have controlled blood pressure. Potential participants should have significant protein in their urine, indicating kidney issues. Those with active infections, certain other kidney problems, or who are pregnant cannot join. If you enroll, you'll be monitored closely throughout the study to assess your response to the treatment. This trial is an important step in finding better ways to help people with this kidney condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • idiopathic membranous nephropathy
• • Female, must be post-menopausal, sterile or have effective contraception
• • must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for or RTX\> 6 months
• • Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive therapy or if patients are intolerant to ACEI/ARB.
• • proteinuria ≥4g/24h and decreased ≤ 50% from baseline
• Exclusion Criteria:
• • presence of active infection or a secondary cause of membranous nephropathy
• • proteinuria associated with diabetic nephropathy
• • pregnancy or breast feeding
• • history of resistance to rituximab or alkylating agents or corticosteroid
• • Patients who previously achieved remission after treatment of rituximab or alkylating agents but relapsed off rituximab or alkylating agents after 6 months are eligible.