Lupus NephritisPhase 3NCT00404157
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
A Phase 3 study testing Rituximab in people with Lupus Nephritis, run by Genentech, Inc..
Trial summary
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Rituximab
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
- Participation in Study U2970g and completion of the Week 52 visit in that study
- For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation
Who cannot join
- Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit
- Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety
- In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit
- Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
- Lack of peripheral venous access
- Pregnancy or lactation
Show all 20Show fewer
- History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
- Significant new or uncontrolled disease in any organ system not related to SLE (e.g., poorly controlled chronic obstructive pulmonary disease or asthma, cardiovascular disease, accelerated hypertension, major depression) that in the investigator's opinion would preclude subject participation
- Known active infection of any kind (excluding fungal infection of nail beds), any major episode of infection requiring hospitalization, or treatment with IV antibiotics within 4 weeks of a study drug infusion or oral antibiotics within 2 weeks of a study drug infusion
- History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
- Major surgery within 4 weeks prior to screening
- Intolerance or contraindication to oral or IV corticosteroids
- Lipase > 2 x the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x the ULN
- Amylase levels > 2 x the ULN
- Absolute neutrophil counts < 1.5 x 10^3/uL
- History of positive hepatitis B surface antigen or hepatitis C serology
- Hemoglobin < 7 g/dL unless caused by autoimmune hemolytic anemia resulting from SLE
- Platelet count < 10,000/uL
- Receipt of a live vaccine within 28 days prior to treatment
About this study
Official title: A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.
- Conditions
- Lupus Nephritis
- Being tested
- Rituximab
- Keywords
- Lupus, U2970g
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.
Secondary outcomes (3)
Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
Serum rituximab levels
Circulating B-cell counts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
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.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Garg, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404157
- Sponsor's protocol ID
- U3388g
- Status last verified
- Apr 2017
- First submitted
- 22 Nov 2006
- Last updated
- 12 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g
- ClinicalTrials.gov ID
- NCT00404157
- Acronym / sponsor ID
- U3388g
- Conditions
- Lupus Nephritis
- Keywords
- Lupus, U2970g
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 27 Nov 2006 (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.
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
- Participation in Study U2970g and completion of the Week 52 visit in that study
- For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation
Key exclusion criteria (20 listed)
- Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit
- Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety
- In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit
- Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
- Lack of peripheral venous access
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 |
|---|---|---|
| Rituximab | Drug | – |
Primary outcome
Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.
3 secondary outcomes
Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
Serum rituximab levels
Circulating B-cell counts.
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 12 Apr 2017.
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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.
Jay Garg, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab in people with Lupus Nephritis, run by Genentech, Inc..
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 3 inclusion and 20 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.. 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 12 Apr 2017.