Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
NCT ID: NCT01226147
Last Updated: 2011-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2010-09-30
2013-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Tamibarotene
4mg/day for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Kinki University
OTHER
Responsible Party
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Department of Nephrology and Rheumatology, Kinki University Faculty of Medicine
Locations
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Kinki University Hospital
Osaka, , Japan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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AM80-F01
Identifier Type: -
Identifier Source: org_study_id
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