Lupus NephritisPhase 3NCT00429377
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
A Phase 3 study testing tacrolimus in people with Lupus Nephritis, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- tacrolimus
- How many people
- 64 participants
- Where
- 7 sitesJapan
- Study dates
- Jun 2003to 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 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Steroid refractory lupus nephritis
- more than 10mg of steroid failed to control disease activity
- patients who failed to reduce the amount of steroid
- patients who couldn't increase the amount of steroid due to side effects
Who cannot join
- Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
- Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
- CNS( Central Nerve System) Lupus patients
- hepatic failure patients
- Serum creatinine ≧1.5mg/dL
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Hokuriku Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
- Conditions
- Lupus Nephritis
- Being tested
- tacrolimus
- Keywords
- tacrolimus, FK506, lupus nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Lupus Nephritis - Disease Activity Index total score
Secondary outcomes (1)
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJun 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429377
- Sponsor's protocol ID
- 506-LN02
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 31 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
- ClinicalTrials.gov ID
- NCT00429377
- Acronym / sponsor ID
- 506-LN02
- Conditions
- Lupus Nephritis
- Keywords
- tacrolimus, FK506, lupus nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- First posted
- 31 Jan 2007 (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 study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Steroid refractory lupus nephritis
Key exclusion criteria (5 listed)
- Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
- Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
- CNS( Central Nerve System) Lupus patients
- hepatic failure patients
- Serum creatinine ≧1.5mg/dL
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 |
|---|---|---|
| tacrolimus | Drug | – |
Primary outcome
Change of Lupus Nephritis - Disease Activity Index total score
1 secondary outcome
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2007.
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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.
Use Central Contact study director
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus in people with Lupus Nephritis, run by Astellas Pharma Inc at 7 sites in Japan.
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 5 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 31 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Lupus Nephritis - Disease Activity Index total score. 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 31 Jan 2007.