Lupus NephritisPhase 2NCT01226147
Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
A Phase 2 study testing Tamibarotene in people with Lupus Nephritis, run by Kinki University at 1 site in Japan.
Trial summary
An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Tamibarotene
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Feb 2013
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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
- Urine Protein creatinine raio > 0.5 or RBC in urine >= 6 /HPF
- Anti dsDNA antibody > 10 IU/ml or complement C3 < 84 mg/dl
- Patients willing to take contraceptive measures throughout the study and for female patients two years after the study and for men six months after the study.
Who cannot join
- Pregnant or breastfeeding female patients
- Hepatic failure patients
- Triglyceride > 500 mg/dl
- Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 8 weeks prior to test drug administration
- Patients who received cyclophosphamide puls within 6 months prior to test drug administration
- Patients with diabetics (HbA1c > 8.0%)
- Serum creatinine ≧1.5mg/dL
- CNS( Central Nerve System) Lupus patients
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kinki University Hospital
Osaka, 5898511
Masanori Funauchi, M.D., mn-funa@med.kindai.ac.jp
Masanori Funauchi, M.D.
About this study
An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis
Read the detailed description
Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, and in US, Europe and China it is still under development for APL. Compared to other retinoid drugs available, Tamibarotene has not just a higher activity as a retinoid, but also shows a higher receptor selectivity towards the Retinoic Acid Receptor (RAR) subtypes alfa and beta, but not gamma. All trans retinoic acid (ATRA) and its derivatives are usually pan-agonists to these subtypes, and often are know for the irritation to the skin as one of their major side effects which is due to the RAR gamma subtype. Moreover, unlike ATRA tamibarotene does not cause induction of drug metabolism by CRABP.
Tamibarotene is known to moderate T1/T2 balance as well as Treg/Th17 balance through binding RAR-alfa receptor, and shows efficacy to various autoimmune and inflammatory animal models.
In the preliminary clinical research, patients with lupus nephritis for whom prednisolone treatment was not sufficient enough was treated with oral administration of ATRA to show a remarkable decrease in their protein urea (ref. Kinoshita et al, Am.J.Kidney Dis., 2009 Jul 21).
Based on these results, the investigators plan by this study to evaluate the efficacy of tamibarotene together with the safety to the patients of lupus nephritis.
Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.
- Conditions
- Lupus Nephritis
- Being tested
- Tamibarotene
- Keywords
- Lupus Nephritis, SLE, retinoid, tamibarotene
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamibaroteneDrug
4mg/day for 24 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function
Measured: 24 weeks
Urinary Protein values
Measured: 24 weeks
Urinary Sediment
Measured: 28 weeks
Anti di-DNA antibody and complement C3
Measured: 28 weeks
Secondary outcomes (3)
Disease activity index, total improvement
Measured: 24 weeks
SLEDAI
Measured: 24 weeks
Safety
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kinki University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226147
- Sponsor's protocol ID
- AM80-F01
- Status last verified
- Jul 2011
- First submitted
- 21 Oct 2010
- Last updated
- 22 Jul 2011
- Results posted
- No
Publications
Kinoshita K, Kishimoto K, Shimazu H, Nozaki Y, Sugiyama M, Ikoma S, Funauchi M. Successful treatment with retinoids in patients with lupus nephritis. Am J Kidney Dis. 2010 Feb;55(2):344-7. doi: 10.1053/j.ajkd.2009.06.012. Epub 2009 Jul 23.
PubMed 19628316
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01226147
- Acronym / sponsor ID
- AM80-F01
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, SLE, retinoid, tamibarotene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kinki UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 22 Oct 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.
An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis
Detailed description
Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, and in US, Europe and China it is still under development for APL. Compared to other retinoid drugs available, Tamibarotene has not just a higher activity as a retinoid, but also shows a higher receptor selectivity towards the Retinoic Acid Receptor (RAR) subtypes alfa and beta, but not gamma. All trans retinoic acid (ATRA) and its derivatives are usually pan-agonists to these subtypes, and often are know for the irritation to the skin as one of their major side effects which is due to the RAR gamma subtype. Moreover, unlike ATRA tamibarotene does not cause induction of drug metabolism by CRABP.
Tamibarotene is known to moderate T1/T2 balance as well as Treg/Th17 balance through binding RAR-alfa receptor, and shows efficacy to various autoimmune and inflammatory animal models.
In the preliminary clinical research, patients with lupus nephritis for whom prednisolone treatment was not sufficient enough was treated with oral administration of ATRA to show a remarkable decrease in their protein urea (ref. Kinoshita et al, Am.J.Kidney Dis., 2009 Jul 21).
Based on these results, the investigators plan by this study to evaluate the efficacy of tamibarotene together with the safety to the patients of lupus nephritis.
Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Steroid refractory lupus nephritis
- Urine Protein creatinine raio > 0.5 or RBC in urine >= 6 /HPF
- Anti dsDNA antibody > 10 IU/ml or complement C3 < 84 mg/dl
- Patients willing to take contraceptive measures throughout the study and for female patients two years after the study and for men six months after the study.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding female patients
- Hepatic failure patients
- Triglyceride > 500 mg/dl
- Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 8 weeks prior to test drug administration
- Patients who received cyclophosphamide puls within 6 months prior to test drug administration
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 |
|---|---|---|
| Tamibarotene4mg/day for 24 weeks. | Drug | – |
Primary outcome
Renal Function
Time frame: 24 weeks
Urinary Protein values
Time frame: 24 weeks
Urinary Sediment
Time frame: 28 weeks
Anti di-DNA antibody and complement C3
Time frame: 28 weeks
3 secondary outcomes
Disease activity index, total improvement
Time frame: 24 weeks
SLEDAI
Time frame: 24 weeks
Safety
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Background: PubMed 19628316Kinoshita K, Kishimoto K, Shimazu H, Nozaki Y, Sugiyama M, Ikoma S, Funauchi M. Successful treatment with retinoids in patients with lupus nephritis. Am J Kidney Dis. 2010 Feb;55(2):344-7. doi: 10.1053/j.ajkd.2009.06.012. Epub 2009 Jul 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamibarotene in people with Lupus Nephritis, run by Kinki University at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 22 Jul 2011. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masanori Funauchi, M.D. (+81-72-366-0221, mn-funa@med.kindai.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Function (time frame: 24 weeks). The study lists 4 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 NCT01226147, which also lists 1 linked publication.
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 22 Jul 2011.