Anesthesia Clinical Trial
Official title:
A Multi-center, Parallel-group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of 4.0 mg/kg Sugammadex Administered at 1-2 PTC in Subjects With Normal or Severely Impaired Renal Function
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.
The results of previous trials showed that the safety profile of sugammadex
observed in subjects with impaired renal function are not appreciably different from
subjects with normal renal function. Reoccurrence of neuromuscular blockade was not
observed, and sugammadex was safe and generally well tolerated in subjects with severe renal
impairment. In a previous trial, subjects (n=15) with severe renal impairment received a
dose of 2.0 mg.kg-1 of sugammadex. The effects of the other proposed recommended dose for
routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied
thus far in subjects with severe renal impairment. The objectives of this trial were to
assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal
function or severe renal impairment, to evaluate the safety of sugammadex in these subject
groups and to compare the pharmacokinetic profiles.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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