NCT05761938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

February 14, 2023

Last Update Submit

February 27, 2023

Conditions

Glomerulonephritis

Keywords

MN;MCD/FSGS;rituximab

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Remission Status

    6 months

  • Remission Status

    16 weeks

  • Relapse

    12 months

  • Incidence of adverse events (AEs)

    12 months

Study Arms (2)

cohort A

pathologically confirmed membranous nephropathy

cohort B

pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary MN, MCD/FSGS patients confirmed by biopsy

You may qualify if:

  • 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

You may not qualify if:

  • 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：
  • HIV infected ( HIV antibody positive )
  • HBV or HCV infection
  • Evidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia )
  • Those currently undergoing clinical trials of other drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

MeSH Terms

Conditions

Glomerulonephritis

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • GENGRU JIANG, doctor

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GENGRU JIANG, doctor

CONTACT

+86-13816238339jianggengru@xinhuamed.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Renal Division, Department of Internal Medicine

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 9, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)