Recruiting

Fexofenadine

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03078777

Conditions

Hemodialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fexofenadine

Study Details

Brief 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.

Conditions

Hemodialysis

Study ID

NCT03078777

Start date

Nov 29, 2017

Status verified date

Nov, 2017

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pre-Dialysis

Patients will take 120 mg of fexofenadine three hours prior to dialysis and plasma concentration measured three hours following dosing.

experimental: Post-Dialysis

Patients will take 120 mg of fexofenadine at the end of their dialysis session and plasma concentration measured three hours following dosing.

Interventions

Fexofenadine

Fexofenadine will be administered to patients.

Primary outcome measure

  • Plasma Fexofenadine Concentration [ Time Frame: 3 hours following dosing ]

Central Contacts and Locations

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Brad Urquhart, PhD

5196613756Brad.Urquhart@schulich.uwo.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Nov 27, 2017

Last verified

Nov, 2017

Keywords

  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-11-27.