Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226147
Recruitment Status : Unknown
Verified July 2011 by Kinki University.
Recruitment status was:  Recruiting
First Posted : October 22, 2010
Last Update Posted : July 22, 2011
Information provided by:
Kinki University

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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Tamibarotene Phase 2

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, 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Tamibarotene
    4mg/day for 24 weeks.

Primary Outcome Measures :
  1. Renal Function [ Time Frame: 24 weeks ]
  2. Urinary Protein values [ Time Frame: 24 weeks ]
  3. Urinary Sediment [ Time Frame: 28 weeks ]
  4. Anti di-DNA antibody and complement C3 [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Disease activity index, total improvement [ Time Frame: 24 weeks ]
  2. SLEDAI [ Time Frame: 24 weeks ]
  3. Safety [ Time Frame: 28 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226147

Contact: Masanori Funauchi, M.D. +81-72-366-0221

Kinki University Hospital Recruiting
Osaka, Japan, 5898511
Contact: Masanori Funauchi, M.D.   
Principal Investigator: Masanori Funauchi, M.D.         
Sponsors and Collaborators
Kinki University

Responsible Party: Masanori Funauchi, MD, Professor, Department of Nephrology and Rheumatology, Kinki University Faculty of Medicine Identifier: NCT01226147     History of Changes
Other Study ID Numbers: AM80-F01
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Kinki University:
Lupus Nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases