Clinical trial NCT05383547: Bortezomib for Treating Glomerular Diseases
Official title: Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bortezomib
Glomerulonephritis
MN
MPGN
FSGS
IgA Nephropathy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete Remission Rate of Proteinuria
timeFrame: One Year
Secondary outcomes:
measure: Safety of Bortezomib
timeFrame: One Year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: