Skip to content

Prospective multicenter randomized controlled study of efficacy and safety of torch flower root tablet in low-risk idiopathic membranous nephropathy

Prospective multicenter randomized controlled study of efficacy and safety of torch flower root tablet in low-risk idiopathic membranous nephropathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001621
Enrollment
Unknown
Registered
2025-08-28
Start date
2023-11-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Idiopathic membranous nephropathy

Interventions

test group:Colquhounia Root Tablets

Sponsors

Ruijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients with renal biopsy-confirmed diagnosis of idiopathic membranous nephropathy and positive renal tissue or serum anti-PLA2R antibodies; 2) Age =18 and =75 years old regardless of gender; 3) eGFR =30 ml/min/1.73m2; 4) 24-hour quantitative urine protein results still between 0.5-4 g after more than 3 months of treatment with a standard-dose ARB; the ARB specified in this trial was irbesartan; 5) Female patients of childbearing age with negative pregnancy test results and consent to use contraception; 6) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients who have received glucocorticoids and immunosuppressants (including but not limited to leflunomide, cyclophosphamide (CTX), cyclosporine, mycophenolate mofetil, tacrolimus, rituximab, etc.) within the last 3 months; 2.Patients with major comorbidities including chronic liver disease, cardiac insufficiency, severe cardiac arrhythmias, myocardial infarction, stroke, uncontrolled hypertension and diabetes, malignancies; 3.Patients with membranous nephropathy secondary to identifiable causes such as systemic lupus erythematosus, HBV/HCV infection, thyroid or other tumors, or organic solvent/heavy metal poisoning; 4.Patients who are pregnant (or planning pregnancy within 6 months), lactating; 5.Patients with known allergy to Torreyagrandis Root Tablets or contraindications for its use.

Design outcomes

Primary

MeasureTime frame
Urine protein quantification at 24 hours;

Secondary

MeasureTime frame
Antiphospholipase A2 Antibody;Urine Protein;

Countries

China

Contacts

Public ContactLiang ying

Xiyuan Hospital China Academy of Chinese Medical Sciences

liangyin@163.com+86 18322923428

Outcome results

None listed

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