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NCT05761938
A Study of Rituximab in Frontline Therapy for Glomerulonephritis
Conditions: Glomerulonephritis
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 100
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Location: China
Summary
This study included patients with glomerulonephritis who planned to receive rituximab treatment, and observed the efficacy and safety of rituximab in different glomerulonephritis in the real world.
According to the pathological types of glomerulonephritis, they were divided into two cohorts : membranous nephropathy ( MN ) group or minimal change disease / focal segmental glomerulosclerosis ( MCD / FSGS ) group.
Eligibility Criteria
Inclusion Criteria:Primary MN, MCD/FSGS patients confirmed by biopsyConsistent with nephrotic syndrome ( urinary protein>3.5g/d
and serum albumin< 30g/L), and the researchers consider that immunosuppressive therapy is neededEstimated glomerular filtration rate ( eGFR≥60 ml/min/1.73m2
)Patients providing written informed consent before initiation of any study-related activitiesExclusion Criteria:Previous treatment of rituximabactive bacteria, fungi, tuberculosis, viral infectionSecondary 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 aboveSevere hypertension ( blood pressure>180/110 mmHg ) that cannot be controlled by drug treatmentPregnant or lactating female patientsUncontrolled concurrent diseases, including but not limited to:HIV infected ( HIV antibody positive )HBV or HCV infectionEvidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia )Those currently undergoing clinical trials of other drugsOther patients considered unsuitable for inclusion by the researchers
Source: ClinicalTrials.gov (NCT05761938). StuddyBuddy aggregates publicly available trial information.