Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers

M. C. Chapelsky, David E. Nix, J. C. Cavanaugh, J. H. Wilton, A. Norman, J. J. Schentag

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

This study assessed the potential nephrotoxicity of clarithromycin in comparison with gentamicin and placebo. Increased urinary excretion of alanine aminopeptidase (AAP) and N-acetyl β-D-glucosaminidase (NAG) served as markers of renal tubular injury. The study utilised a mutiple-dose, double-blind, randomised, parallel group design. 14 healthy male subjects received of 3 treatment regimens: (a) clarithromycin 500 mg orally every 12 h for 13 doses and intravencus placebo every 8 h (n = 5); (b) oral placebo every 12 h and intravenous placebo every 8 h (n = 4 and (c) intravenous gentamicin 1.7 mg/kg every 8 h for 19 doses and oral placebo every 12 h (p = 5). 24h urine collections were obtained daily for determinations of AAP and NAG activities. Gentamicin produced statistically significant increases (p < 0.0001) in AAP and NAG excretion, with increases as early as the first and second day of dosing. Clarithromycin, when compared with placebo, did not produce significant elevations in AAP or NAG activity. On the basis of these data, it is unlikely that usual doses of clarithromycin have significant potential for causiag nephrotoxicity.

Original languageEnglish (US)
Pages (from-to)304-309
Number of pages6
JournalDrug Safety
Volume7
Issue number4
StatePublished - 1992
Externally publishedYes

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CD13 Antigens
Clarithromycin
Gentamicins
Volunteers
Hexosaminidases
Placebos
Kidney
Enzymes
Urine Specimen Collection
Healthy Volunteers
Wounds and Injuries

ASJC Scopus subject areas

  • Health, Toxicology and Mutagenesis
  • Public Health, Environmental and Occupational Health
  • Pharmacology
  • Toxicology

Cite this

Chapelsky, M. C., Nix, D. E., Cavanaugh, J. C., Wilton, J. H., Norman, A., & Schentag, J. J. (1992). Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers. Drug Safety, 7(4), 304-309.

Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers. / Chapelsky, M. C.; Nix, David E.; Cavanaugh, J. C.; Wilton, J. H.; Norman, A.; Schentag, J. J.

In: Drug Safety, Vol. 7, No. 4, 1992, p. 304-309.

Research output: Contribution to journalArticle

Chapelsky, MC, Nix, DE, Cavanaugh, JC, Wilton, JH, Norman, A & Schentag, JJ 1992, 'Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers', Drug Safety, vol. 7, no. 4, pp. 304-309.
Chapelsky MC, Nix DE, Cavanaugh JC, Wilton JH, Norman A, Schentag JJ. Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers. Drug Safety. 1992;7(4):304-309.
Chapelsky, M. C. ; Nix, David E. ; Cavanaugh, J. C. ; Wilton, J. H. ; Norman, A. ; Schentag, J. J. / Renal tubular enzyme effects of clarithromycin in comparison with gentamicin and placebo in volunteers. In: Drug Safety. 1992 ; Vol. 7, No. 4. pp. 304-309.
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