Efficacy and Safety of Steroid Combined with Mycophenolate Mofetil Regimen in the Treatment of Primary Membranous Nephropathy Patients with Double High-Risk Factors

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600125299

Enrollment

Unknown

Registered

2026-05-25

Start date

2026-05-26

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

primary membranous nephropathy

Interventions

Intervention group:Steroid with mycophenolate mofetil

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18-80 years old. 2. Patients diagnosed with primary membranous nephropathy (PMN) at high risk of disease progression who meet at least two of the following three criteria have strong indications for immunosuppressive therapy: a. Serum creatinine level > 133 µmol/L attributable to active membranous nephropathy; b. Progressive renal function decline caused by active membranous nephropathy, with an eGFR reduction of no less than 25% compared with the baseline value within six months; c. Severe and life-threatening nephrotic syndrome characterized by serum albumin < 25 g/L, refractory edema or thromboembolic events. 3. Judged by clinicians, patients show intolerance or relative contraindications to first-line immunosuppressive regimens: a. High risk of infection: history of opportunistic infections such as fungal infection, cryptococcosis and Pneumocystis jirovecii pneumonia (PJP); b. No high infection risk but complicated with the following conditions: For cyclophosphamide (CTX) regimen: intolerance due to myelosuppression or liver injury, high cumulative dosage (one full course of CTX previously administered), history of malignancy, or fertility demand; For rituximab (RTX) regimen: allergic reaction, serum creatinine elevation after administration, treatment failure, or unaffordable medical expenses;? For calcineurin inhibitor (CNI) regimen: treatment failure, elevated baseline creatinine, and high risk of acute kidney injury (AKI) after CNI application.

Exclusion criteria

Exclusion criteria: 1. Secondary membranous nephropathy; 2. Refusal to participate and sign the informed consent form; 3. Presence of active infection; 4. Malignancies that may affect life expectancy in the short term.

Design outcomes

Primary

Measure	Time frame
overall remission rate;	—

Secondary

Measure	Time frame
Serum Creatinine;Serum Albumin;Urine Protein;Adverse Event (AE);	—

Countries

China

Contacts

Public ContactQionghong Xie

Huashan Hospital, Fudan University

qionghongxie@fudan.edu.cn+86 181 2118 6869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026