Bortezomib for Treating Glomerular Diseases

IgA Nephropathy Clinical Trial

Official title:

Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383547
• Other study ID #: KY2022-53
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bortezomib
• FSGS
• Glomerulonephritis
• Glomerulonephritis, IGA
• IgA Nephropathy
• MN

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate of Proteinuria	24h Proteinuria <300mg/24h	One Year
Secondary	Safety of Bortezomib	Incidence of Treatment-Emergent Adverse Events	One Year