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A randomized controlled study of rituximab in combination with short-term corticosteroids or tacrolimus for primary membranous nephropathy

A randomized controlled study of rituximab in combination with short-term corticosteroids or tacrolimus for primary membranous nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076737
Enrollment
Unknown
Registered
2023-10-17
Start date
2023-10-31
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

primary membranous nephropathy

Interventions

A:Prednisone acetate+rituximab
B:Tacrolimus+rituximab
C:rituximab

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Patients who meet the diagnostic criteria for primary membranous nephropathy for initial treatment. ? Age >18 years and 3.5g)in the nephrotic range after non-immunotherapy and an estimated GFR value >45ml/(min·1.73m2)(calculated according to the CKD-EPI formula). ? Those who voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: ? Combined renal disease in addition to primary membranous nephropathy. ? Evidence of severe and irreversible renal damage (e.g., ultrasound showing a kidney <8 cm or renal biopsy with severe interstitial fibrosis, tubular atrophy, or glomerulosclerosis). ? Combined tumor, active infection, organ failure, cognitive impairment, myocardial infarction, severe arrhythmia, ALT elevation greater than 1.5 times the upper limit of normal, and severe hematopoietic disorders. ? Pregnant or lactating women or women planning to become pregnant within the next 24 months who have contraindications or allergies to the trial drug. ? Subjects who are participating in clinical trials of other drugs. ? Those who, in the investigator's opinion, are otherwise unsuitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
complete remission/ partial remission;

Secondary

MeasureTime frame
Plasma albumin, PLA2R Ab/TSHD7A Ab levels;median time to remission, relapse rate and rate of patients with >30% decrease in eGFR at the last follow-up, side effects;

Countries

China

Contacts

Public ContactGaosi Xu

The Second Affiliated Hospital of Nanchang University

xugaosi@126.com+86 150 7916 0103

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026