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Protocol for a Clinical Study Utilizing Big Data and a Multi-center Randomized Controlled Trial to Evaluate the Application of Collateral Disease Theory in Membranous Nephropathy

Protocol for a Clinical Study Utilizing Big Data and a Multi-center Randomized Controlled Trial to Evaluate the Application of Collateral Disease Theory in Membranous Nephropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000087
Enrollment
Unknown
Registered
2026-01-17
Start date
2025-03-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Membranous Nephropathy

Interventions

Experimental Group:The experimental group receives the corresponding syndrome-specific Chinese medicine granules used in this trial, in addition to the baseline therapy, stratified therapy, and follow
Control Group:The Control Group receives baseline therapy + stratified therapy + placebo Chinese medicine granules.

Sponsors

Hangzhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for idiopathic membranous nephropathy; (2) Age between 18 and 75 years (inclusive), regardless of gender; (3) Classified as low, moderate, or high risk according to the 2021 KDIGO guideline risk stratification; (4) Glomerular filtration rate (GFR) >30 ml/min; (5) Present with Qi deficiency and blood stasis pattern based on Traditional Chinese Medicine syndrome differentiation; (6) Voluntarily agree to participate in the study, comply with scheduled follow-ups, and provide signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Age under 18 or over 75 years; (2) Diagnosed with secondary membranous nephropathy (SMN), such as patients with MN pathological manifestations caused by viral infections, malignancies, etc.; (3) Patients with a familial genetic predisposition to MN; (4) Use of glucocorticoids or immunosuppressants within the past month; (5) Classified as very high risk according to the 2021 KDIGO guidelines, or presenting with drug-resistant fluid overload, hyperkalemia, metabolic acidosis, severe anemia, etc., requiring consideration of renal replacement therapy; (6) Complicated with severe infections; (7) Pregnant or lactating women, individuals with psychiatric disorders, allergic constitution, or multiple drug allergies; (8) Allergy to Chinese herbal medicine granules; (9) Participation in other clinical drug trials.

Design outcomes

Primary

MeasureTime frame
Proteinuria;

Secondary

MeasureTime frame
Serum albumin;Traditional Chinese Medicine Syndrome Scoring;Anti-PLA2R levels;24-hour urinary protein quantification;Urine albumin/creatinine;Glomerular filtration rate;Modified Kidney Disease Quality of Life Short Form (KDQOL-SF);

Countries

China

Contacts

Public ContactZhu Caifeng

Hangzhou Hospital of Traditional Chinese Medicine

zhcaifeng@126.com+86 189 5807 7658

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026