Prognostic Model of Rituximab in the Treatment of MN

Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Observational Model:
Time Perspective:
Official Title:
Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Rituximab
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment

Drug: Rituximab
375mg/m2 once a week, 4 times in total, or 1g intravenous drip, once again after 2 weeks, twice in total.


Drug: Rituximab
375mg/m2 once a week, 4 times in total, or 1g intravenous drip, once again after 2 weeks, twice in total.

Outcome Measures

Primary Outcome Measures

  1. Remission of the State of MN [6 months]

    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.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. 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;

  2. 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.

  3. 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;

  4. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.

Exclusion Criteria:
  1. There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;

  2. At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;

  3. 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;

  4. During follow-up, the patient cannot actively cooperate or accurately understand and express.

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Qianfoshan Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Zunsong Wang, Principal Investigator, Qianfoshan Hospital Identifier:
Other Study ID Numbers:
  • IMN-Rituximab
First Posted:
Dec 29, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2022