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Antihistamine
The Effect Dialysis on the Pharmacokinetics of Fexofenadine
Phase 4
Waitlist Available
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patients treated by any dialysis modality (e.g. hemodialysis, peritoneal dialysis) for at least 90 days prior to study enrolment.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours following dosing
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours following dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours following dosing
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma Fexofenadine Concentration
Side effects data
From 2023 Phase 3 trial • 95 Patients • NCT056921544%
Oedema mucosal
4%
Headache
4%
Nasal obstruction
2%
Neck pain
2%
Nasal oedema
2%
Back pain
2%
Skin abrasion
2%
Seasonal allergy
2%
Arthralgia
2%
Sinus headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Active-active)
Arm B (Placebo-active)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pre-DialysisExperimental Treatment1 Intervention
Patients will take 120 mg of fexofenadine three hours prior to dialysis and plasma concentration measured three hours following dosing.
Group II: Post-DialysisExperimental Treatment1 Intervention
Patients will take 120 mg of fexofenadine at the end of their dialysis session and plasma concentration measured three hours following dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fexofenadine
FDA approved
Find a Location
Who is running the clinical trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
670 Previous Clinical Trials
418,325 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,390 Total Patients Enrolled