Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
1 other identifier
interventional
20
1 country
1
Brief Summary
An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJuly 22, 2011
July 1, 2011
2.4 years
October 21, 2010
July 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Renal Function
24 weeks
Urinary Protein values
24 weeks
Urinary Sediment
28 weeks
Anti di-DNA antibody and complement C3
28 weeks
Secondary Outcomes (3)
Disease activity index, total improvement
24 weeks
SLEDAI
24 weeks
Safety
28 weeks
Interventions
4mg/day for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinki Universitylead
Study Sites (1)
Kinki University Hospital
Osaka, 5898511, Japan
Related Publications (1)
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.
PMID: 19628316BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
July 22, 2011
Record last verified: 2011-07