NDLI: Lack of Effect of DX-619, a Novel Des-Fluoro(6)-Quinolone, on Glomerular Filtration Rate Measured by Serum Clearance of Cold Iohexol▿

Content Provider	PubMed Central
Author	Sarapa, Nenad Prachi, Wickremasingha Ge, Nanxiang Weitzman, Richard Fuellhart, Merynda Yen, Cindy Julia, Lloyd-parks
Copyright Year	2007
Abstract	DX-619 is a novel des-fluoro(6)-quinolone with activity against a broad range of bacterial strains, including methicillin-resistant Staphylococcus aureus. The effects of DX-619 on the glomerular filtration rate (GFR) were evaluated because drug-related increases in serum creatinine levels were observed in studies with healthy volunteers. Forty-one healthy subjects were randomized to receive intravenous DX-619 at 800 mg or placebo once daily for 4 days, and the GFR was directly measured by determination of the clearance of a bolus iohexol injection in 33 subjects who completed the study per protocol. DX-619 was noninferior to placebo for the GFR on the basis of a criterion for a clinically significant difference of −12 ml/min/1.73 m2. The mean GFRs on day 4 were 101.1 ± 14.2 ml/min/1.73 m2 and 100.2 ± 15.6 ml/min/1.73 m2 for the volunteers receiving placebo and DX-619, respectively. On day 4 the mean serum creatinine concentration for volunteers receiving DX-619 increased by 30 to 40%, with a corresponding decrease in mean creatinine clearance. Both parameters normalized within 7 days after the cessation of DX-619 treatment. Nonclinical studies suggest that DX-619 increases the serum creatinine concentration by inhibiting excretory tubular transporters. In conclusion, DX-619 administered intravenously at 800 mg once a day for 4 days did not affect the GFR in healthy volunteers. Glomerular toxicity is not expected to present a risk to patients receiving DX-619 in clinical trials, but monitoring of the renal function, with an emphasis on the serum creatinine concentration, is still warranted.
Related Links	http://dx.doi.org/10.1128/AAC.01223-06
Starting Page	1912
File Format	PDF
ISSN	10986596
e-ISSN	10986596
Journal	Antimicrobial Agents and Chemotherapy
Issue Number	6
Volume Number	51
Language	English
Publisher	American Society for Microbiology
Publisher Date	2007-06-01
Access Restriction	Open
Rights Holder	American Society for Microbiology
Subject Keyword	Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Pharmacology Pharmacology (medical)

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