The Effect Dialysis on the Pharmacokinetics of Fexofenadine

Hemodialysis Clinical Trial

Official title: The Effect Dialysis on the Pharmacokinetics of Fexofenadine

Status Recruiting

Clinical Trial Summary

The Investigators recently completed and published a study that demonstrated that fexofenadine pharmacokinetics are significantly altered in dialysis patients (Thomson et al. (2015) American Journal of Kidney Diseases 65(4):574-582). In this study, patients were studied directly before routine dialysis treatment. Other published literature suggests the timing of the dose of some drugs (before or after dialysis) may have a profound impact on the drug pharmacokinetics (Nolin et al (2006) 17(9):2363-7). The hypothesis is that compounds that accumulate in the blood of patients with kidney failure impact the pharmacokinetics such that dosing before or after dialysis produces significantly different blood levels of the drug.

Clinical Trial Description

This will be an open, randomized pharmacokinetic study in 30 patients treated by dialysis. Patients will be asked to spend an additional 3 hours at the hospital on each of two study days separated by at least a week. At the first study visit, the patient will be randomized to receive the drug fexofenadine (120 mg, orally) either 3 hour prior to, OR at the conclusion of their regularly scheduled dialysis treatment. Three hours following fexofenadine administration, a single 4 mL (approximately 1 teaspoon) blood sample will be drawn. One week or more after the first study day, the patient will have the study repeated but with the timing of the dose altered to match the randomization. For example, if at the first study visit the patient received fexofenadine after their dialysis session, they will now receive the drug 3 hours prior to their dialysis session. The blood sample will be centrifuged immediately and plasma stored at -80 celsius until analysis. Fexofenadine concentration will be determine by liquid chromatography coupled to mass spectrometry. ;

Related Conditions & MeSH terms

• Hemodialysis

• NCT number: NCT03078777
• Study type: Interventional
• Source: Lawson Health Research Institute
• Status: Recruiting
• Phase: Phase 4
• Start date: November 29, 2017
• Completion date: August 2020