- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078777
The Effect Dialysis on the Pharmacokinetics of Fexofenadine
November 23, 2017 updated by: Lawson Health Research Institute
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A5A5
- Recruiting
- London Health Sciences Centre
-
Contact:
- Brad Urquhart, PhD
- Phone Number: 5196613756
- Email: Brad.Urquhart@schulich.uwo.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-Dialysis
Patients will take 120 mg of fexofenadine three hours prior to dialysis and plasma concentration measured three hours following dosing.
|
Fexofenadine will be administered to patients.
|
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.
|
Fexofenadine will be administered to patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Fexofenadine Concentration
Time Frame: 3 hours following dosing
|
Measurement of Plasma Fexofenadine Concentration
|
3 hours following dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 29, 2017
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
March 7, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 13, 2017
Study Record Updates
Last Update Posted (Actual)
November 27, 2017
Last Update Submitted That Met QC Criteria
November 23, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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