Chronic Kidney DiseasePhase 4NCT01103778

Pilot Study of Velcade® in IgA Nephropathy

A Phase 4 study testing Bortezomib (Velcade®) in people with Chronic Kidney Disease and IgA Nephropathy, run by The Rogosin Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, IgA Nephropathy
What is being tested?: Bortezomib (Velcade®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Jul 2010to 17 Apr 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Rogosin Institute
New York, New York, 10021

Other trials in United States

About this study

Official title: Velcade Therapy for Severe IgA Nephropathy

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.

Read the 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.

Conditions: Chronic Kidney Disease, IgA Nephropathy
Being tested: Bortezomib (Velcade®)
Keywords: Chronic kidney disease, IgA nephropathy, Velcade®, Proteinuria, Bortezomib, Proteasome inhibitor
Medical subject headings: Renal Insufficiency, Chronic, Glomerulonephritis, IGA, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01103778
Study group	Role	What they receive
Velcade® therapy	Experimental	Patients with greater than 1gm of proteinuria per day will receive Velcade®. Receives: Drug: Bortezomib (Velcade®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proteinuria
Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.
Measured: Baseline and 1 year
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.
Measured: 1 year

Secondary outcomes (2)

Serum Creatinine
Preservation of renal function will be assessed.
Measured: Baseline and 1 year
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201017 Apr 2017

First posted15 Apr 2010 (estimated)
Study startJul 2010
Primary completion17 Apr 2017
Study completion17 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103778
Sponsor's protocol ID: X05320
Other IDs: 1001010854
Status last verified: Oct 2018
First submitted: 13 Apr 2010
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29988921
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.
PubMed 26032537
Hartono C, Muthukumar T. Treating IgA nephropathy: quid novi? Discov Med. 2014 Mar;17(93):131-8.
PubMed 24641955

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Velcade Therapy for Severe IgA Nephropathy
ClinicalTrials.gov ID: NCT01103778
Acronym / sponsor ID: X05320
Conditions: Chronic Kidney Disease, IgA Nephropathy
Keywords: Chronic kidney disease, IgA nephropathy, Velcade®, Proteinuria, Bortezomib, Proteasome inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: The Rogosin InstituteUniversity, hospital or other
Collaborators: Weill Medical College of Cornell University
Study start: Jul 2010
Primary completion: 17 Apr 2017 (actual)
Study completion: 17 Apr 2017 (actual)
First posted: 15 Apr 2010 (estimated)
Results: Posted 17 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Velcade® therapy	Experimental	Drug: Bortezomib (Velcade®)Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bortezomib (Velcade®)Also: Velcade®, BortezomibVelcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).	Drug	Velcade® therapy

Primary outcome

Proteinuria
Time frame: Baseline and 1 year
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.
Time frame: 1 year
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.

2 secondary outcomes

Serum Creatinine
Time frame: Baseline and 1 year
Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.
Time frame: 1 year

Results and safety

Results posted to the registry on 17 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Velcade Arm	11	8

Primary outcome: Proteinuria

Time frame: Baseline and 1 year. Median (Full Range). Unit: grams per 24 hrs

Measure	Velcade® Therapy n = 7
Baseline	2.52 (1.17 to 4.96)
1 year	1.43 (0.10 to 4.23)

Population analysed: 1 participant was lost to followup.

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

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Velcade Arm n = 7
Complete Remission	3
Partial Response	1
No Response	3

Population analysed: 1 participant was lost to followup.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Velcade® Therapy	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Limitations and caveats (from the sponsor): Our pilot study has several significant limitations, including small sample size, no control group, and nonrandomization.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29988921Hartono 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.
Derived from this study: PubMed 26032537Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Derived from this study: PubMed 24641955Hartono C, Muthukumar T. Treating IgA nephropathy: quid novi? Discov Med. 2014 Mar;17(93):131-8.
The Rogosin InstituteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Choli Hartono, MD principal investigator

The Rogosin Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bortezomib (Velcade®) in people with Chronic Kidney Disease and IgA Nephropathy, run by The Rogosin Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proteinuria (time frame: Baseline and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103778, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.