A Study of Rituximab in Frontline Therapy for Glomerulonephritis

February 27, 2023 updated by: Gengru Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • Changhai Hospital
        • Contact:
          • zhiyong guo, doctoral
      • Shanghai, China
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • leyi gu, doctoral
      • Shanghai, China
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • wen zhang, doctoral
      • Shanghai, China
        • Not yet recruiting
        • Shanghai 6th People's Hospital
        • Contact:
          • niansong wang, doctoral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary MN, MCD/FSGS patients confirmed by biopsy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
cohort A
pathologically confirmed membranous nephropathy
cohort B
pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission Status
Time Frame: 12 months

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
Remission Status
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission Status
Time Frame: 6 months
The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab.
6 months
Remission Status
Time Frame: 16 weeks
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.
16 weeks
Relapse
Time Frame: 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
12 months
Incidence of adverse events (AEs)
Time Frame: 12 months
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: GENGRU JIANG, doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-22-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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