Status:
UNKNOWN
Bortezomib for Treating Glomerular Diseases
Lead Sponsor:
Ruijin Hospital
Conditions:
Bortezomib
Glomerulonephritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05383547
Start Date
August 2 2022
End Date
December 31 2023
Last Update
October 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025