A Study of Rituximab in Frontline Therapy for Glomerulonephritis

Glomerulonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761938
• Other study ID #: XH-22-011
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: GENGRU JIANG, doctor
• Phone: +86-13816238339
• Email: jianggengru[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai
China	Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai 6th People's Hospital	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission Status	The number of subjects who achieve complete remission or partial remission in MN cohort at 12 months after treatment with Rituximab.; CR was defined as urinary protein quantitative<0.3g and Albutein>35g/L in 24 hours.; PR was defined as urinary protein quantitative>0.3g,but<3.5g or urinary protein decreased by 50% compared with the baseline level and the renal function was stable ( serum creatinine increased by<20% compared with the baseline level ) in 24 hours.	12 months
Primary	Remission Status	The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 8 weeks after treatment with Rituximab.	8 weeks
Secondary	Remission Status	The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab.	6 months
Secondary	Remission Status	The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.	16 weeks
Secondary	Relapse	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	12 months
Secondary	Incidence of adverse events (AEs)	Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.	12 months