Document Detail


Management of young patients with lupus nephritis using tacrolimus administered as a single daily dose.
MedLine Citation:
PMID:  19954719     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Studies on immunosuppressive treatment with tacrolimus (Tac) in subjects with lupus nephritis (LN) are limited. Here, we report our experience with Tac administered daily as a single-dose for maintenance therapy in young patients with pediatric-onset, long-standing LN. METHODS: Eleven consecutive patients with long-standing biopsy-proven LN were recruited for at least 6 months or longer (6 - 24 months) as part of an open-label trial for the single-daily-dose administration of Tac (3 mg/day, 0.04 - 0.075 mg/kg) without dose increases of concomitantly administered prednisolone (PDN). Tac treatment was started at the time of the most recent flare. Data on clinical parameters and serologic lupus activity were collected prospectively. RESULTS: The baseline characteristics of the patients were as follows: mean age, 18 years; urinary protein/creatinine ratio (Up/cr), 0.74 +/- 1.49; serum C3 level, 69.5 +/- 26.5 mg/dl (normal 79 - 152 mg/dl); serum complement hemolytic activity (CH50), 23.0 +/- 8.9 U/ml (normal 23 - 46 U/ml); serum anti-dsDNA antibody titer, 58.9 +/- 54.2 IU/ml (normal < 12.0 IU/ml); serum creatinine, 0.54 +/- 0.13 mg/dl; and European Consensus Lupus Activity Measurement (ECLAM) index, 4.4 +/- 2.2. Despite the gradual tapering of the PDN dose, a marked improvement, compared with the baseline values was observed in the ECLAM index even at 1 month and in the serological parameters at 3 months after the start of treatment. These favorable results persisted until the end of the study. The Up/cre ratio gradually decreased and had dropped significantly at 24 months after the start of treatment. After a mean of 18 months of treatment, complete responses were achieved in 8 patients (73%) and a partial response was achieved in 2 patients. The remaining one patient showed no response. No serious adverse effects were observed. CONCLUSION: These data suggest that low-dose Tac treatment, administered once daily, is an effective and safe method for managing selected young patients with pediatric-onset, long-standing LN. However, further studies involving a larger number of patients are needed to confirm these results.
Authors:
H Tanaka; E Oki; K Tsuruga; T Yashiro; I Hanada; E Ito
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Clinical nephrology     Volume:  72     ISSN:  0301-0430     ISO Abbreviation:  Clin. Nephrol.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-03     Completed Date:  2010-02-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0364441     Medline TA:  Clin Nephrol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  430-6     Citation Subset:  IM    
Affiliation:
Department of Pediatrics, Hirosaki University School of Medicine, 5 Zaifu-cho, Hirosaki, 036-8562, Japan. hirotana@cc.hirosaki-u.ac.jp
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antibodies, Antinuclear / blood
Biopsy
Complement C3 / metabolism
Complement Hemolytic Activity Assay
DNA / immunology
Dose-Response Relationship, Drug
Drug Administration Schedule
Enzyme-Linked Immunosorbent Assay
Female
Follow-Up Studies
Humans
Immunosuppressive Agents / administration & dosage*
Lupus Nephritis / drug therapy*,  metabolism,  pathology
Male
Prospective Studies
Tacrolimus / administration & dosage*
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Antibodies, Antinuclear; 0/Complement C3; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 9007-49-2/DNA

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