A Study of Rituximab in Frontline Therapy for Glomerulonephritis

Recruiting

• Conditions: Glomerulonephritis

• Registration Number: NCT05761938
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

A total of 100 patients with glomerulonephritis who planned to receive rituximab treatment were enrolled in the study. According to the pathological types of glomerulonephritis, they were divided into MN cohort and MCD / FSGS cohort, with 50 patients in each cohort. All eligible patients who meet the inclusion and exclusion criteria will be invited to participate in this study.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission Status	8 weeks	The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 8 weeks after treatment with Rituximab.

Secondary Outcome Measures

Name	Time	Method
Relapse	12 months	The number of subjects who relapse within 12 months in MCD/FSGS cohort. A relapse is defined as reappearance of Urine Protein Creatinine Ratio (based on 24-hour urine collection) \> 3.5 after complete or partial remission
Remission Status	16 weeks	The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.
Incidence of adverse events (AEs)	12 months	Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Trial Locations

Locations (5)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Changhai Hospital; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China