Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinki University

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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