A Phase 1 interventional study of telavancin in Kidney Diseases and End Stage Renal Disease, sponsored by Cumberland Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Cumberland Pharmaceuticals · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 45 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Cumberland Pharmaceuticals is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
An estimated creatinine clearance value based on Cockcroft-Gault method of:
Exclusion Criteria:
Subjects with normal renal function
Drug: telavancin
Subjects with severe renal impairment
Drug: telavancin
Subjects with end stage renal disease
Drug: telavancin
Intravenous
Also known as: VIBATIV®, TD-6424, ASP9809
Concentration of telavancin as estimated by antibiotic potency bioassay
Time frame: Days 1-4
Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)
Time frame: Days 1-4
Pharmacokinetic variables through analysis of blood samples
Time frame: Days 1-4
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Cumberland Pharmaceuticals