Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Recruiting
Shanghai
Time Frame
Start Date: June 1, 2022
Estimated Completion Date: July 31, 2023
Participants
Target number of participants: 20
Treatments
Experimental: Glomerular disease patients
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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