Bortezomib for Treating Glomerular Diseases

NCT ID: NCT05383547

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-12-31

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.

Conditions

Bortezomib; Glomerulonephritis; MN; MPGN; FSGS; IgA Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glomerular disease patients

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Dexamethasone 10mg+ bortezomib (1.3mg /m2 IV) was administered at D1,D4,D8,D11, one month for 1 cycle, for 2 cycles.

Interventions

Bortezomib

Dexamethasone 10mg+ bortezomib (1.3mg /m2 IV) was administered at D1,D4,D8,D11, one month for 1 cycle, for 2 cycles.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nan Chen,MD

Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Li Lin

Role: primary

sn2011linli@126.com

008602174370045

Other Identifiers

KY2022-53

Identifier Type: -

Identifier Source: org_study_id