Skip to content

A clinical interventional single-arm study of cyclophosphamide in combination with membranous nephropathy

A clinical interventional single-arm study of cyclophosphamide in combination with membranous nephropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000355
Enrollment
Unknown
Registered
2025-02-19
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Membranous nephropathy

Interventions

Intervention group:Cyclophosphamide oral combined with Shuli Fraction Formula, 1 dose per day (before-after control)

Sponsors

Dongzhimen hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: All patients were diagnosed with biopsy-proven positive MN or serum anti-PLA2R antibodies. Patients meet the following criteria prior to starting combination therapy: 1) age 18-80 years; 2) eGFR > 30ml/min/1.73m2 3) Pathologically confirmed membranous nephropathy (stage 1-4) or positive PLA2R antibody by renal biopsy; 4) Meet the diagnostic criteria for intermediate- and high-risk MND; Referring to the 2024 KDIGO Clinical Management Guidelines for Glomerular Diseases and the Up to date guidelines the evaluation was carried out according to the temporal trend of clinical and serological parameters. 5) In patients who have received RASi for more than 3 months the amount of proteinuria is still > 3.5g/d; 6) No prior treatment with hormones and other immunosuppressants.

Exclusion criteria

Exclusion criteria: 1) Those who are pregnant lactating or have recently planned to become pregnant; 2) Indications for the need for corticosterol immunotherapy; 3) Other types of membranous nephropathy such as rapidly progressive membranous nephropathy (rapid loss of kidney function: 50% decrease in eGFR within 3 months) and secondary membranous nephropathy such as infections autoimmune diseases drugs tumors heavy metals etc.; 4) Use or are using steroid medications or other immunosuppressants in the past 6 months; 5) Heart failure abnormal liver function abnormal coagulation function and current infection; 6) Those who are allergic to the drug of this study; 7) Patients with severe mental illness or cognitive impairment who cannot cooperate with treatment; 8) malignant/uncontrolled hypertension; 9) Other causes of current renal instability such as acute kidney injury caused by massive hematuria; 10) White blood cell count < 3.0×109 /L or other blood disorders; 11) ECG showing prolonged QT interval or severe arrhythmias; 12) Concomitant administration of medications that can cause QT interval prolongation; 13) Patients who in the opinion of the supervising physician are unable to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
Remission rate;

Secondary

MeasureTime frame
anti-PLA2R;24hUTP;Alb;blood lipids;Scr;

Countries

China

Contacts

Public ContactDuyiran

Dongzhimen hospital

18810535596@163.com18810535596

Outcome results

None listed

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