Using rituximab for treating glomerulonephritis

A Multicenter, Prospective, Real World Study of Rituximab in Frontline Therapy for Glomerulonephritis

This study is testing how well rituximab works and how safe it is for people with different types of glomerulonephritis.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: rituximab
• Locations: 5 sites (Shanghai and 4 other locations)
• Trial ID: NCT05761938 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with glomerulonephritis who are set to receive rituximab treatment. It aims to evaluate the efficacy and safety of rituximab across different types of glomerulonephritis, specifically dividing participants into two cohorts: those with membranous nephropathy and those with minimal change disease or focal segmental glomerulosclerosis. A total of 100 patients will be enrolled, with 50 in each cohort, to gather real-world data on treatment outcomes. Participants must meet specific inclusion and exclusion criteria to ensure the validity of the findings.

Who should consider this trial

Good fit: Ideal candidates include adults with primary membranous nephropathy or minimal change disease/focal segmental glomerulosclerosis confirmed by biopsy.

Not a fit: Patients with secondary forms of glomerulonephritis or those who have previously received rituximab are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of rituximab for patients with glomerulonephritis, potentially leading to improved treatment protocols.

How similar studies have performed: While the use of rituximab in glomerulonephritis has been explored, this specific observational approach is relatively novel and aims to provide real-world evidence.

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

Where this trial is running

Shanghai and 4 other locations

• Changhai Hospital — Shanghai, China (Not_yet_recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Shanghai 6th People's Hospital — Shanghai, China (Not_yet_recruiting)
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: GENGRU JIANG, doctor — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: GENGRU JIANG, doctor

Conditions Glomerulonephritis; MN; MCD/FSGS; rituximab