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Prospective multicenter randomized double-blind placebo-controlled clinical study on the efficacy and safety of membranous Fuyuan granules in the treatment of moderate and low risk idiopathic membranous nephropathy

Prospective multicenter randomized double-blind placebo-controlled clinical study on the efficacy and safety of membranous Fuyuan granules in the treatment of moderate and low risk idiopathic membranous nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000688
Enrollment
Unknown
Registered
2024-11-11
Start date
2024-11-16
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

idiopathic membranous nephropathy

Interventions

Treatment Group:MoShenFuYuan granule treatment

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with idiopathic membranous nephropathy confirmed by renal biopsy whose renal tissue or serum is positive for anti-PLA2R antibody; (2) Age =18 years old and =75 years old gender is not limited; (3) eGFR=60ml/min/1.73m2; (4) TCM syndroms are consistent with spleen-kidney qi deficiency and phlegm stasis interjunction syndrome; (5) After treatment with standard dose of ARB for more than 3 months the urinary protein quantity in 24 hours was still between 1.0-6.0g; In this experiment ARB was designated as irbesartan; (6) Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who received glucocorticoids and immunosuppressants in the last 3 months including but not limited to leflunomide cyclophosphamide (CTX) cyclosporine tacrolimus mycophenolate ester rituximab etc; (2) Chronic liver disease heart dysfunction myocardial infarction stroke uncontrolled hypertension diabetes malignant tumors and other major diseases; (3) Systemic lupus erythematosus hepatitis B hepatitis C virus infection thyroid and other tumors organic solvents heavy metal poisoning and other clear secondary causes of membranous nephropathy; (4) pregnant (or pregnant within half a year) and lactating patients; (5) Known allergies or contraindications to some components of membranshenfuyuan granules.

Design outcomes

Primary

MeasureTime frame
24-hour proteinuria;serum albumin;serum total protein;

Secondary

MeasureTime frame
serum creatinine;;Urinary microalbumin creatinine ratio;;Serum PLA2R antibody;serum urea nitrogen;;Estimate glomerular filtration rate;;

Countries

China

Contacts

Public ContactRenHuan Yu

Xiyuan Hospital of China Academy of Chinese Medical Sciences

tezhongeyu@vip.sina.com13611196162

Outcome results

None listed

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