Idiopathic Membranous NephropathyNCT05667909
Prognostic Model of Rituximab in the Treatment of MN
An observational study of Idiopathic Membranous Nephropathy, run by Qianfoshan Hospital.
Trial summary
The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of rituximab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic membranous nephropathy diagnosed at age 18-75 years
Who may be able to join
- Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;
- According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.
- In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;
- Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
Who cannot join
- There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
- At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
- The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;
- During follow-up, the patient cannot actively cooperate or accurately understand and express.
About this study
Official title: Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Rituximab
The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of rituximab. The main questions it aims to answer are:
- to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of rituximab
- to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of rituximab treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.
Researchers will compare [remission group and non-remission group] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Rituximab
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375mg/m2 once a week, 4 times in total, or 1g intravenous drip, once again after 2 weeks, twice in total.
| Study group | Role | What they receive |
|---|---|---|
| Remission | Not described Receives: Drug: Rituximab | |
| Non-remission | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of the State of MN
- None-Remission of the State of MN: 1) 24-hour urin protein (24-h UP)>3.5 g, or 24-h UP<50% lower than the baseline, or serum creatinine increased by 50% compared with the baseline; 2) Renal function progress: Compared with the initial examination, estimated glomerular filtration rate (eGFR) progress is greater than or equal to 30%; 3) End stage renal disease: eGFR<15ml/min, or renal replacement therapy.
- Partial Remission of the State of MN: 24-h UP is 0.5-3.5 g, and 24-h UP is more than 50% lower than the baseline, serum creatinine is normal, and plasma albumin is ≥ 30 g.
- Complete Remission of the State of MN: 24-h UP<0.5g, serum creatinine normal, plasma albumin ≥ 35g.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study startJun 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667909
- Sponsor's protocol ID
- IMN-Rituximab
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Rituximab
- ClinicalTrials.gov ID
- NCT05667909
- Acronym / sponsor ID
- IMN-Rituximab
- Conditions
- Idiopathic Membranous Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Dec 2022 (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.
The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of rituximab. The main questions it aims to answer are:
- to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of rituximab
- to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of rituximab treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.
Researchers will compare [remission group and non-remission group] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remission | – | Drug: Rituximab |
| Non-remission | – | Drug: Rituximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic membranous nephropathy diagnosed at age 18-75 years
Key inclusion criteria (4 listed)
- Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;
- According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.
- In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;
- Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
Key exclusion criteria (4 listed)
- There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
- At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
- The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;
- During follow-up, the patient cannot actively cooperate or accurately understand and express.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab375mg/m2 once a week, 4 times in total, or 1g intravenous drip, once again after 2 weeks, twice in total. | Drug | Non-remission, Remission |
Primary outcome
Remission of the State of MN
Time frame: 6 months
1. None-Remission of the State of MN: 1) 24-hour urin protein (24-h UP)>3.5 g, or 24-h UP<50% lower than the baseline, or serum creatinine increased by 50% compared with the baseline; 2) Renal function progress: Compared with the initial examination, estimated glomerular filtration rate (eGFR) progress is greater than or equal to 30%; 3) End stage renal disease: eGFR<15ml/min, or renal replacement therapy. 2. Partial Remission of the State of MN: 24-h UP is 0.5-3.5 g, and 24-h UP is more than 50% lower than the baseline, serum creatinine is normal, and plasma albumin is ≥ 30 g. 3. Complete Remission of the State of MN: 24-h UP<0.5g, serum creatinine normal, plasma albumin ≥ 35g.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Membranous Nephropathy, run by Qianfoshan Hospital.
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 4 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of the State of MN (time frame: 6 months). 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 17 Mar 2023.