Bortezomib for Treating Glomerular Diseases

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05383547

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bortezomib Glomerulonephritis MN MPGN FSGS IgA Nephropathy	Drug: Bortezomib	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glomerular disease patients	Drug: Bortezomib Dexamethasone 10mg+ bortezomib (1.3mg /m2 IV) was administered at D1,D4,D8,D11, one month for 1 cycle, for 2 cycles.

Arm

Intervention/Treatment

Experimental: Glomerular disease patients

Drug: Bortezomib

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

Outcome Measures

Primary Outcome Measures

Complete Remission Rate of Proteinuria [One Year]
24h Proteinuria <300mg/24h

Secondary Outcome Measures

Safety of Bortezomib [One Year]
Incidence of Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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, Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT05383547

Other Study ID Numbers: