GlomerulonephritisNCT05761938
A Study of Rituximab in Frontline Therapy for Glomerulonephritis
An observational study of Glomerulonephritis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glomerulonephritis
- How many people
- 100 participants
- Where
- 5 sitesChina
- Study dates
- 1 Feb 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Primary MN, MCD/FSGS patients confirmed by biopsy
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
- Other patients considered unsuitable for inclusion by the researchers
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Changhai Hospital
Shanghai
zhiyong guo, doctoral
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
leyi gu, doctoral
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
wen zhang, doctoral
- Not yet recruiting
Shanghai 6th People's Hospital
Shanghai
niansong wang, doctoral
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
gengru JIANG, doctoral, +86-13816238339, jianggengru@xinhuamed.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Glomerulonephritis
- Keywords
- MN;MCD/FSGS;rituximab
- Medical subject headings
- Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort A | pathologically confirmed membranous nephropathy | |
| cohort B | pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
Remission Status
The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab.
Measured: 6 months
Remission Status
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.
Measured: 16 weeks
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gengru Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- GENGRU JIANG, doctor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761938
- Sponsor's protocol ID
- XH-22-011
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Real World Study of Rituximab in Frontline Therapy for Glomerulonephritis
- ClinicalTrials.gov ID
- NCT05761938
- Acronym / sponsor ID
- XH-22-011
- Conditions
- Glomerulonephritis
- Keywords
- MN;MCD/FSGS;rituximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort A | – | –pathologically confirmed membranous nephropathy |
| cohort B | – | –pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary MN, MCD/FSGS patients confirmed by biopsy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
Remission Status
Time frame: 6 months
Remission Status
Time frame: 16 weeks
Relapse
Time frame: 12 months
Incidence of adverse events (AEs)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Glomerulonephritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GENGRU JIANG, doctor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerulonephritis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GENGRU JIANG, doctor (+86-13816238339, jianggengru@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission Status (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.