Lupus NephritisPhase 4NCT01169857
Velcade for Proliferative Lupus Nephritis
A Phase 4 study testing Velcade in people with Lupus Nephritis and Proteinuria, run by The Rogosin Institute at 1 site in United States.
Trial summary
The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis, Proteinuria, Hematuria
- What is being tested?
- Velcade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- ACR criteria for lupus (minimum 4 out of 11).
- Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
- GFR must be greater or equal to 30 cc/min/1.73 m2.
- Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
- Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Who cannot join
- Serum creatinine of more than 3.0 mg/dL on repeated testing.
- Greater than 50% fibrosis on renal biopsy.
- Platelet count of less than 30× 109/L.
- Absolute neutrophil count of less than 1.0 × 109/L.
- Greater than or equal to Grade 1 peripheral neuropathy.
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
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- Hypersensitivity to Velcade, boron or mannitol.
- Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
- Known history of untreated positive PPD.
- Serious complications from systemic lupus such as cerebral lupus and severe active infections.
- Diagnosed or treated for another malignancy within 3 years of enrollment.
- Greater than 1.5x upper limit of normal total bilirubin.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.
Read the detailed description
This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.
- Conditions
- Lupus Nephritis, Proteinuria, Hematuria
- Being tested
- Velcade
- Keywords
- Proliferative lupus nephritis, WHO class III/IV/V lupus nephritis, Proteinuria, Hematuria, Velcade, SLE, Bortezomib, Proteasome inhibitor
- Medical subject headings
- Lupus Nephritis, Proteinuria, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
Also called Bortezomib, Proteasome inhibitor
Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
| Study group | Role | What they receive |
|---|---|---|
| Velcade Therapy | Experimental | Not described Receives: Drug: Velcade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Quantification of 24 hr urinary protein.
Measured: 1 year
Secondary outcomes (2)
Renal function
Serum creatinine and GFR
Measured: 1 year
Lupus activity score
Assessment of SELENA-SLEDAI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Choli Hartono, MD, Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169857
- Sponsor's protocol ID
- X05321
- Other IDs
- 1003010960
- Status last verified
- Apr 2012
- First submitted
- 23 Jul 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade for Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01169857
- Acronym / sponsor ID
- X05321
- Conditions
- Lupus Nephritis, Proteinuria, Hematuria
- Keywords
- Proliferative lupus nephritis, WHO class III/IV/V lupus nephritis, Proteinuria, Hematuria, Velcade, SLE, Bortezomib, Proteasome inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.
Detailed description
This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade Therapy | Experimental | Drug: Velcade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ACR criteria for lupus (minimum 4 out of 11).
- Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
- GFR must be greater or equal to 30 cc/min/1.73 m2.
- Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
- Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
Key exclusion criteria (12 listed)
- Serum creatinine of more than 3.0 mg/dL on repeated testing.
- Greater than 50% fibrosis on renal biopsy.
- Platelet count of less than 30× 109/L.
- Absolute neutrophil count of less than 1.0 × 109/L.
- Greater than or equal to Grade 1 peripheral neuropathy.
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 |
|---|---|---|
| VelcadeAlso: Bortezomib, Proteasome inhibitorVelcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy. | Drug | Velcade Therapy |
Primary outcome
Proteinuria
Time frame: 1 year
Quantification of 24 hr urinary protein.
2 secondary outcomes
Renal function
Time frame: 1 year
Lupus activity score
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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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 Velcade in people with Lupus Nephritis and Proteinuria, 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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 24 Apr 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2012.