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Pilot Study of Velcade® in IgA Nephropathy

Primary Purpose

Chronic Kidney Disease, IgA Nephropathy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bortezomib (Velcade®)

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, IgA nephropathy, Velcade®, Proteinuria, Bortezomib, Proteasome inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18 years of age or older.
Must have IgA nephropathy documented by kidney biopsy.
Must have greater than 1gm of proteinuria a day.
Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

Exclusion Criteria:

Low platelet count and neutrophil count within certain limits defined for enrollment.
Underlying peripheral neuropathy.
Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Allergic to VELCADE®, boron or mannitol.
Female subjects who are pregnant or breast-feeding.
Recent use of investigational drug within 14 days before enrollment.
Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.

Sites / Locations

The Rogosin Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Velcade® therapy

Arm Description

Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Outcomes

Primary Outcome Measures

Proteinuria

Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

Number of Participants With Complete Remission, Partial Response, or no Response.

Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection. Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection.

Secondary Outcome Measures

Serum Creatinine

Preservation of renal function will be assessed.

Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.

Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.

Full Information

NCT ID

NCT01103778

First Posted

April 13, 2010

Last Updated

October 16, 2018

Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT01103778

Brief Title

Pilot Study of Velcade® in IgA Nephropathy

Official Title

Velcade Therapy for Severe IgA Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

April 17, 2017 (Actual)

Study Completion Date

April 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy. The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.

Detailed Description

This exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe IgA nephropathy. Subjects will receive 1 cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a year. For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, IgA Nephropathy

Keywords

Chronic kidney disease, IgA nephropathy, Velcade®, Proteinuria, Bortezomib, Proteasome inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Velcade® therapy

Arm Type

Experimental

Arm Description

Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Intervention Type

Drug

Intervention Name(s)

Bortezomib (Velcade®)

Other Intervention Name(s)

Velcade®, Bortezomib

Intervention Description

Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).

Primary Outcome Measure Information:

Title

Proteinuria

Description

Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

Time Frame

Baseline and 1 year

Title

Number of Participants With Complete Remission, Partial Response, or no Response.

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Serum Creatinine

Description

Preservation of renal function will be assessed.

Time Frame

Baseline and 1 year

Title

Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.

Description

Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18 years of age or older. Must have IgA nephropathy documented by kidney biopsy. Must have greater than 1gm of proteinuria a day. Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening. Exclusion Criteria: Low platelet count and neutrophil count within certain limits defined for enrollment. Underlying peripheral neuropathy. Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Allergic to VELCADE®, boron or mannitol. Female subjects who are pregnant or breast-feeding. Recent use of investigational drug within 14 days before enrollment. Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study. Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Choli Hartono, MD

Organizational Affiliation

The Rogosin Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rogosin Institute

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29988921

Citation

Hartono C, Chung M, Perlman AS, Chevalier JM, Serur D, Seshan SV, Muthukumar T. Bortezomib for Reduction of Proteinuria in IgA Nephropathy. Kidney Int Rep. 2018 Mar 11;3(4):861-866. doi: 10.1016/j.ekir.2018.03.001. eCollection 2018 Jul.

Results Reference

result

PubMed Identifier

26032537

Citation

Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.

Results Reference

derived

PubMed Identifier

24641955

Citation

Hartono C, Muthukumar T. Treating IgA nephropathy: quid novi? Discov Med. 2014 Mar;17(93):131-8.

Results Reference

derived

Links:

URL

http://www.rogosin.org

Description

The Rogosin Institute

Learn more about this trial

Pilot Study of Velcade® in IgA Nephropathy

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