Clinical trial NCT05761938: A Study of Rituximab in Frontline Therapy for Glomerulonephritis
Official title: A Multicenter, Prospective, Real World Study of Rituximab in Frontline Therapy for Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glomerulonephritis
Keywords: MN;MCD/FSGS;rituximab
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary MN, MCD/FSGS patients confirmed by biopsy

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.

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

Primary outcomes:
measure: Remission Status
timeFrame: 12 months
measure: Remission Status
timeFrame: 8 weeks
Secondary outcomes:
measure: Remission Status
timeFrame: 6 months
measure: Remission Status
timeFrame: 16 weeks
measure: Relapse
timeFrame: 12 months
measure: Incidence of adverse events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: GENGRU JIANG, doctor
role: PRINCIPAL_INVESTIGATOR
References: