A Study of Rituximab in Frontline Therapy for Glomerulonephritis

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called rituximab as a first-line treatment for patients with glomerulonephritis, a condition that affects the kidneys. The researchers want to see how effective and safe rituximab is for patients with different types of this condition, specifically those diagnosed with membranous nephropathy or minimal change disease/focal segmental glomerulosclerosis. The trial is currently looking for participants aged between 65 and 74 who have been confirmed to have these conditions through a biopsy and have symptoms indicating they need immunosuppressive therapy.

If you are interested in participating, you would need to meet certain criteria, such as having significant protein in your urine and low levels of albumin in your blood. However, if you have previously been treated with rituximab, have certain infections, or other specific health conditions, you might not be eligible. Participants in the study can expect regular check-ups and monitoring to track the treatment's effects and safety. It’s important to note that the trial is still recruiting new participants, and those who join will contribute to valuable research that could improve treatment for kidney diseases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Primary MN, MCD/FSGS patients confirmed by biopsy
• • Consistent with nephrotic syndrome ( urinary protein\>3.5g/d and serum albumin\< 30g/L), and the researchers consider that immunosuppressive therapy is needed
• • Estimated glomerular filtration rate ( eGFR≥60 ml/min/1.73m2 )
• • Patients providing written informed consent before initiation of any study-related activities
• Exclusion Criteria:
• • Previous treatment of rituximab
• • active bacteria, fungi, tuberculosis, viral infection
• • Secondary MN, MCD, FSGS ( such as active hepatitis, systemic lupus erythematosus, drugs, malignant tumors, genetic or diabetic nephropathy, etc. )
• • Severe cardiac insufficiency, cardiac function in NYHA grade III above
• • Severe hypertension ( blood pressure\>180/110 mmHg ) that cannot be controlled by drug treatment
• • Pregnant or lactating female patients
• • Uncontrolled concurrent diseases, including but not limited to：
• • 1. HIV infected ( HIV antibody positive )
• • 2. HBV or HCV infection
• • 3. Evidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia )
• • Those currently undergoing clinical trials of other drugs
• • Other patients considered unsuitable for inclusion by the researchers