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Bortezomib for Treating Glomerular Diseases

Primary Purpose

Bortezomib, Glomerulonephritis, MN

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bortezomib

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glomerular disease patients

Arm Description

Outcomes

Primary Outcome Measures

Complete Remission Rate of Proteinuria
24h Proteinuria <300mg/24h

Secondary Outcome Measures

Safety of Bortezomib
Incidence of Treatment-Emergent Adverse Events

Full Information

First Posted
May 10, 2022
Last Updated
October 28, 2022
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05383547
Brief Title
Bortezomib for Treating Glomerular Diseases
Official Title
Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bortezomib, Glomerulonephritis, MN, MPGN, FSGS, IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glomerular disease patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Dexamethasone 10mg+ bortezomib (1.3mg /m2 IV) was administered at D1,D4,D8,D11, one month for 1 cycle, for 2 cycles.
Primary Outcome Measure Information:
Title
Complete Remission Rate of Proteinuria
Description
24h Proteinuria <300mg/24h
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Safety of Bortezomib
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Lin
Phone
008602174370045
Email
sn2011linli@126.com

12. IPD Sharing Statement

Learn more about this trial

Bortezomib for Treating Glomerular Diseases

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