Lupus Nephritis Clinical Trial
An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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