Bortezomib for Treating Glomerular Diseases

NCT05383547 | Unknown

• 1 other identifier: KY2022-53
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete Remission Rate of Proteinuria

  24h Proteinuria \<300mg/24h

  One Year

Secondary Outcomes (1)

• Safety of Bortezomib

  One Year

Study Arms (1)

Glomerular disease patients

EXPERIMENTAL

Drug: Bortezomib

Interventions

Bortezomib DRUG

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

Glomerular disease patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glomerular diseases confirmed by renal biopsy (including IgA nephropathy, membranous nephropathy, FSGS, etc.)
• Aged 18-65, male or female
• Signed informed consent
• h 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis; Glomerulonephritis, IGA

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 20, 2022
• Study Start: August 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-05

Locations

CN (1)