Renal tolerance of digoxin-specific Fab fragments in the rat.

Renal markers were investigated over 96 h in male Sprague-Dawley rats after i.v. administration of 10.7 mg kg(-1) of digoxin-specific Fab fragments (DSFab). The dose was calculated by an allometric equation as equivalent to a high clinical dose. DSFab both alone and pre-incubated with digoxin were tested. None of the markers (creatinine clearance, fractional excretion of sodium, urinary activities of gamma-glutamyl transferase and alkaline phosphatase) were significantly altered in treated rats compared to control rats. Thus no renal toxicity due to DSFab alone or bound to digoxin was observed when administered at 10.7 mg kg(-1) in rats.