Status:
UNKNOWN
Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
Lead Sponsor:
Kinki University
Conditions:
Lupus Nephritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01226147
Start Date
September 1 2010
End Date
February 1 2013
Last Update
July 22 2011
Active Locations (1)
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1
Kinki University Hospital
Osaka, Japan, 5898511