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Antihistamine

Pre-Dialysis for Hemodialysis

Phase 4
Waitlist Available
Research Sponsored by Lawson Health Research Institute
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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours following dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours following dosing for reporting.

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 • NCT05692154
4%
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?

Lawson Health Research InstituteLead Sponsor
677 Previous Clinical Trials
421,597 Total Patients Enrolled
~4 spots leftby Nov 2025
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