NCT03078777

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

March 7, 2017

Last Update Submit

November 23, 2017

Conditions

Hemodialysis

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma Fexofenadine Concentration

    Measurement of Plasma Fexofenadine Concentration

    3 hours following dosing

Study Arms (2)

Pre-Dialysis

EXPERIMENTAL

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

Drug: Fexofenadine

Post-Dialysis

EXPERIMENTAL

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

Drug: Fexofenadine

Interventions

FexofenadineDRUG

Fexofenadine will be administered to patients.

Post-DialysisPre-Dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

MeSH Terms

Interventions

fexofenadine

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 13, 2017

Study Start

November 29, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)