The Effect Dialysis on the Pharmacokinetics of Fexofenadine

Hemodialysis Clinical Trial

Official title:

The Effect Dialysis on the Pharmacokinetics of Fexofenadine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03078777
• Other study ID #: 108170
• Status: Recruiting
• Phase: Phase 4
• First received: March 7, 2017
• Last updated: November 23, 2017
• Start date: November 29, 2017
• Est. completion date: August 2020

Study information

• Verified date: November 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated by any dialysis modality (e.g. hemodialysis, peritoneal dialysis) for at least 90 days prior to study enrolment.

Exclusion Criteria:

• Current or recent (within two weeks) hepatic or gastrointestinal morbidity. Inability or refusal to provide written informed consent. Unable to provide a blood sample. Female patients that are pregnant will be excluded.

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Drug:
• Fexofenadine
Fexofenadine will be administered to patients.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Fexofenadine Concentration	Measurement of Plasma Fexofenadine Concentration	3 hours following dosing