Bortezomib for Treating Glomerular Diseases

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Bortezomib is a proteasome inhibitor that inhibits autoantibody production, and reduces podocyte damage and mesangial hyperplasia caused by NF-κB activation in the kidney. Literature has reported that bortezomib can achieve a complete response rate of up to 38% in the treatment of glomerular diseases, but its safety and effectiveness remain to be assessed for the Chinese demographic. This study attempts to explore a new treatment plan for glomerular disease by observing the therapeutic effect of bortezomib on glomerular disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Glomerular diseases confirmed by renal biopsy (including IgA nephropathy, membranous nephropathy, FSGS, etc.)

• Aged 18-65, male or female

• Signed informed consent

• 24h proteinuria >1.5g/24h

• Glomerular filtration rate (eGFR) >30ml/min/1.73m2 (calculated according to CKD-EPI formula) within 14 days before enrollment.

• Blood pressure <140/90mmHg after drug treatment

• Unless there are contraindications, subjects must take a steady dose of ACEI and/or ARB for at least 4 weeks before screening

Exclusion Criteria:

• Renal pathology: glomerulosclerosis ratio >70%, interstitial fibrosis > severe

• Received immunosuppressant treatment within the past 6 months

• Inability to tolerate bortezomib

• Platelet count < 30×109/L within 14 days before enrollment

• Neutrophil count < 1.0×109/L within 14 days before enrollment

• Subjects had >grade 2 peripheral neuropathy within 14 days before enrollment

• ECG evidence of myocardial infarction or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or acute ischemia or active conduction system abnormalities within 6 months before enrollment

• Abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN

• Newly diagnosed malignant tumor (within 5 years) or undergoing radiotherapy/chemotherapy

• Women who are pregnant or breast-feeding, or women of childbearing age who cannot guarantee effective contraception

• New serious life-threatening infections

• Active infectious diseases such as active tuberculosis, active viral hepatitis, HIV infection.

• Mental disorders and psychotropic drug uses

• Patients with an estimated life expectancy of fewer than 12 months

• Patients that were difficult to follow up on or had poor compliance

• Patients who do not wish to sign the form of informed consent