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Comparative Efficacy and Safety of Different Immunosuppressive Regimens for Idiopathic Membranous Nephropathy: A Retrospective Clinical Study

Comparative Efficacy and Safety of Different Immunosuppressive Regimens for Idiopathic Membranous Nephropathy: A Retrospective Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129269
Enrollment
Unknown
Registered
2026-08-03
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Membranous Nephropathy

Interventions

Modified-dose rituximab treatment group:None

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The patient visited the Affiliated Hospital of Guangdong Medical University (January 1, 2019 - December 31, 2024); 2.Age >= 18 years; 3.Confirmed as idiopathic membranous nephropathy by renal biopsy; 4. eGFR > 30 mL/min/1.73 m². 5.Received treatment with rituximab (administration regimen: 500 mg, intravenous infusion, once every two weeks, four times as one course + prednisone 0.5 mg/kg/day, orally) or received conventional treatment (glucocorticoids combined with cyclophosphamide, administration regimen: prednisone 0.5 mg/kg/day, orally, after 6-8 weeks of treatment, reduce the original dose by 5-10% every 2 weeks, subsequently taper slowly based on the condition. Cyclophosphamide: 0.8g-1g per month, intravenous infusion, continued for 3-6 months, total cumulative dose 4-6g). 6.Possess complete baseline clinical data and have obtained follow-up data after at least 6 months of treatment. Inclusion criteria for the external literature group: 1.Priority should be given to randomized controlled trials (RCTs) and cohort studies published within the last 5 years, with a preference for studies conducted in East Asian or Chinese populations. Cohort studies must be of high quality, either prospective or retrospective. 2. The baseline mean values of major baseline parameters, including age, baseline renal function (e.g., glomerular filtration rate, serum creatinine, and blood urea nitrogen), baseline UPCR, and baseline anti-PLA2R antibody levels, should be comparable to the baseline means of the modified rituximab group. 3. Treatment should consist of rituximab administered at standard doses (either 375 mg/m² per dose once weekly for 4 weeks, or 1 g per dose at a two-week interval), without combination with other immunosuppressants. 4. The literature should provide specific sample size numbers, remission rates at 1, 3, and 6 months of follow-up, and the incidence of adverse events. 5. The definition of clinical remission used in the literature should be consistent with that adopted in this study.

Exclusion criteria

Exclusion criteria: 1.Combined with other primary kidney diseases or end-stage renal disease, renal replacement therapy is required.Combine diabetic nephropathy, malignant tumors, autoimmune diseases (such as systemic lupus erythematosus, AIDS); 2.Received treatment with either of the two drugs involved in this study or other specific potent immunosuppressants such as tacrolimus within the 6 months prior to study enrollment; 3.Pregnant or breastfeeding women; 4.The follow-up data is incomplete. Exclusion criteria for external literature: 1. Studies involving combination therapy of rituximab with corticosteroids or other immunosuppressants.Studies using non-standard rituximab dosages (e.g., low dose 2000 mg per course), or those with unclear dosing regimens. 2.Studies with incomplete outcome measures (e.g., missing remission rate data at 1, 3, or 6 months), or those where primary data cannot be extracted (e.g., data presented only in figures/graphs without specific numerical values). 3.Duplicate publications, conference abstracts, reviews, case reports, animal experiments, or other non-clinical research literature.

Design outcomes

Secondary

MeasureTime frame
Creatinine, estimated glomerular filtration rate (eGFR), urea, cystatin C, electrolytes;White blood cell count, red blood cell count, hemoglobin, platelet count;Alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, total protein, albumin, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein;Absolute count of T and B cells;Serum PLA2R antibody level;

Primary

MeasureTime frame
Urine protein-to-creatinine ratio, 24-hour urine protein quantification;

Countries

China

Contacts

Public ContactXu Yongzhi

Affiliated Hospital of Guangdong Medical University

lxyzhi@126.com+86 759 2387414

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026