Bortezomib for Treating Glomerular Diseases

Not Applicable

• Conditions: MN; Bortezomib; Glomerulonephritis; MPGN; FSGS; IgA Nephropathy
• Interventions: Drug: Bortezomib

• Registration Number: NCT05383547
• Lead Sponsor: Ruijin Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-20
• Study Start: 2022-08-02
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glomerular disease patients	Bortezomib	-

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate of Proteinuria	One Year	24h Proteinuria \<300mg/24h

Secondary Outcome Measures

Name	Time	Method
Safety of Bortezomib	One Year	Incidence of Treatment-Emergent Adverse Events

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China