Overview

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