Lupus NephritisPhase 3NCT01342016
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
A Phase 3 study testing tacrolimus capsule, leflunomide tablet and prednisone in people with Lupus Nephritis, run by Astellas Pharma Inc at 12 sites in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- tacrolimus capsule, leflunomide tablet and prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 12 sitesChina
- Study dates
- Apr 2011to May 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body weight 40-100kg
- diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
- diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
- 24hr proteinuria ≥2g and/or active urinary sediments
Who cannot join
- receiving immunosuppressant
- receiving routine treatment of tacrolimus and leflunomide within 1 month
- receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
- history of allergy to tacrolimus and leflunomide
- anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
- planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation
- serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) < 30ml/min
- diabetes mellitus patients
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Study site
Beijing
Study site
Fujian
Study site
Hubei
Study site
Hunan
Study site
Jiangsu
Study site
Jilin City
Study site
Liaoning
Study site
Shandong
Study site
Shanghai
Study site
Shanxi
Study site
Sichuan
Study site
Zhejiang
About this study
Official title: A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- tacrolimus capsule, tacrolimus placebo, leflunomide tablet, leflunomide placebo, prednisone
- Keywords
- prograf, nephritis, leflunomide, immunosuppressant
- Medical subject headings
- Lupus Nephritis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus capsuleDrug
Also called prograf, FK506
oral
tacrolimus placeboDrug
oral
leflunomide tabletDrug
Also called airuohua
oral
leflunomide placeboDrug
oral
prednisoneDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus group | Experimental | tacrolimus capsule + leflunomide placebo Receives: Drug: tacrolimus capsule; Drug: leflunomide placebo; Drug: prednisone |
| leflunomide group | Active comparator | tacrolimus placebo + leflunomide tablet Receives: Drug: tacrolimus placebo; Drug: leflunomide tablet; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission rate (partial remission + complete remission)
Measured: at 6 months after treatment
Secondary outcomes (4)
urinary protein excretion for 24 hrs (24hr proteinuria)
Measured: at 12 weeks and 24 weeks
serum albumin level
Measured: at 12 weeks and 24 weeks
serum creatinine level
Measured: at 12 weeks and 24 weeks
estimated glomerular filtration rate (eGFR)
Measured: at 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Due to safety concern of active control drug
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342016
- Sponsor's protocol ID
- F506-CL-0911
- Status last verified
- Oct 2014
- First submitted
- 25 Apr 2011
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets
- ClinicalTrials.gov ID
- NCT01342016
- Acronym / sponsor ID
- F506-CL-0911
- Conditions
- Lupus Nephritis
- Keywords
- prograf, nephritis, leflunomide, immunosuppressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to safety concern of active control drug
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Apr 2011 (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 purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tacrolimus group | Experimental | Drug: tacrolimus capsule, Drug: leflunomide placebo, Drug: prednisonetacrolimus capsule + leflunomide placebo |
| leflunomide group | Active comparator | Drug: tacrolimus placebo, Drug: leflunomide tablet, Drug: prednisonetacrolimus placebo + leflunomide tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- body weight 40-100kg
- diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
- diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
- 24hr proteinuria ≥2g and/or active urinary sediments
Key exclusion criteria (8 listed)
- receiving immunosuppressant
- receiving routine treatment of tacrolimus and leflunomide within 1 month
- receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
- history of allergy to tacrolimus and leflunomide
- anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
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 capsuleAlso: prograf, FK506oral | Drug | tacrolimus group |
| tacrolimus placebooral | Drug | leflunomide group |
| leflunomide tabletAlso: airuohuaoral | Drug | leflunomide group |
| leflunomide placebooral | Drug | tacrolimus group |
| prednisoneoral | Drug | leflunomide group, tacrolimus group |
Primary outcome
remission rate (partial remission + complete remission)
Time frame: at 6 months after treatment
4 secondary outcomes
urinary protein excretion for 24 hrs (24hr proteinuria)
Time frame: at 12 weeks and 24 weeks
serum albumin level
Time frame: at 12 weeks and 24 weeks
serum creatinine level
Time frame: at 12 weeks and 24 weeks
estimated glomerular filtration rate (eGFR)
Time frame: at 12 weeks and 24 weeks
Results and safety
The study was stopped early (reason given: Due to safety concern of active control drug). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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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 chair
Astellas Pharma Inc
12 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 capsule, leflunomide tablet and prednisone in people with Lupus Nephritis, run by Astellas Pharma Inc at 12 sites in China.
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: stopped early, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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 was stopped early (reason given: Due to safety concern of active control drug). Results are not available in the source record.
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?
remission rate (partial remission + complete remission) (time frame: at 6 months after treatment). 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 17 Oct 2014.