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A comparative study on the efficacy of rituximab combined with tacrolimus and methylprednisolone in the treatment of patients with moderate-high risk idiopathic membranous nephropathy

A comparative study on the efficacy of rituximab combined with tacrolimus and methylprednisolone in the treatment of patients with moderate-high risk idiopathic membranous nephropathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260515001
Enrollment
198
Registered
2026-05-15
Start date
2021-10-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Idiopathic membranous nephropathy (IMN) Rituximab

Interventions

Methylprednisolone tablets were taken orally. The initial dose was 16-24 mg once daily. The dosage was reduced following the recovery of the patient&#039
s condition, and the medication was consumed for 8 weeks. The dosage was reduced by 10% every 2 weeks, and finally the maintenance dose of 8-12 mg was used for clinical treatment. Total treatment dura
s condition stabilized (usually from week 8 of treatment), with a 10% reduction every two weeks, finally maintaining at a dose of 8
Methylprednisolone,Rituximab + Methylprednisolone,Tacrolimus + Methylprednisolone

Sponsors

Binzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients within ages of 18 and 80 2.Patients with idiopathic membranous nephropathy (IMN) 3.Have received the treatment according to this research protocol for more than 6 months 4.Patients without cognitive impairment or communication disorders

Exclusion criteria

Exclusion criteria: 1.Individuals who are allergic or hypersensitive to the study drug 2.Patients with secondary membranous nephropathy caused by infections, autoimmune diseases, tumors, or drugs 3.Patients who are breastfeeding or pregnant 4.Patients with a serum creatinine (SCr) continuously higher than 309 umol/L or an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 and a kidney length diameter lower than 8 cm. 5.Patients suffering from serious or perhaps fatal infections

Design outcomes

Primary

MeasureTime frame
Total effective rate 6 months after treatment Clinical efficacy is complete remission partial remission or ineffective Total effective rate equals complete plus partial divided by total times 100 percent

Secondary

MeasureTime frame
Renal function indicators 3 months and 6 months 24 hour urine protein quantification BUN SCr and ALB levels measured by automatic biochemical analyzer,PLA2R levels 3 months and 6 months Serum M type phospholipase A2 receptor antibody levels detected by enzyme linked immunosorbent assay ELISA,Inflammatory indicators 3 months and 6 months hs CRP IL 6 and CXCL13 levels measured by ELISA or chemiluminescence immunoassay,Urine immune indicators 3 months and 6 months Urinary IgG4 and C5b 9 concentrations determined by enzyme linked immunosorbent assay ELISA,Quality of life 3 months and 6 months SF 36 Short Form Health Survey score ranging from 0 to 100 with higher scores indicating better quality of life,Adverse reactions Throughout the 6 month treatment period Incidence rate of adverse reactions including hair loss nausea vomiting fever infection liver function impairment and gastrointestinal reactions graded by CTCAE version 5.0

Countries

China

Contacts

Public ContactWeiwei Li

Binzhou people's Hospital

liweiwei19862026@163.com18364981162

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Jun 29, 2026