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A Randomized Controlled Trial Comparing Traditional Chinese Medicine vs Glucocorticoids Plus Cyclophosphamide for the Treatment of Refractory Membranous Nephropathy.

Sino-Western Clinical Collaboration Project on Major and Complex Diseases: A Randomized Controlled Trial (RCT) Comparing Chinese Herbal Medicine vs Glucocorticoids Plus Cyclophosphamide for the Treatment of Refractory Membranous Nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002481
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

membranous nephropathy

Interventions

Control Group:Glucocorticoids + Cyclophosphamide + Western medicine basic treatment
Experimental Group:Jianpi Xiusong Granules (Standardized Traditional Chinese Medicine Formulation) + Western Medicine Basic Treatment

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-70 years 2) Confirmed primary MN (confirmed by renal biopsy) 3) Meet either of the following conditions: - Positive anti-PLA2R antibodies and ineffective after adequate first-line immunosuppressive therapy (antibodies persisting =200 RU/mL); - Negative anti-PLA2R antibodies and still presenting nephrotic syndrome after adequate first-line immunosuppressive therapy; 4) Baseline criteria: - 24-hour urine protein =3.5g; - Plasma albumin <30g/L; - eGFR =30 mL/min/1.73m²; 5) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Secondary MN (e.g., lupus nephritis); 2) With severe conditions (NYHA III-IV heart failure, active hepatitis); 3) Within the past 6 months, used traditional Chinese medicine; 4) Pregnant/lactating women; 5) Subjects with cumulative CTX dose exceeding 10g; 6) Subjects with a history of malignancy; 7) Subjects with contraindications to glucocorticoid use;

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantification;anti-PLA2R antibody titer;

Secondary

MeasureTime frame
Serum Creatinine;Serum albumin;blood lipids;

Countries

China

Contacts

Public ContactDeng Yueyi

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

sh_dengyueyi@163.com18917763063

Outcome results

None listed

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