Back to resultsRemoval of Beta Blocker Drugs by Hemodialysis
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Beta blocker
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Kidney Diseases focused on measuring hemodialysis, dialytic clearance, pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.
Exclusion Criteria:
- gastrointestinal or liver disease, body mass index greater than 40 kg/m2, contraindications for receiving a beta blocker (treatment with contraindicated medications, prior adverse reaction, severe reactive airway disease, hemodynamic instability during dialysis).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Atenolol
Bisoprolol
Metoprolol
Carvedilol
Arm Description
Atenolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Bisoprolol (5 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Metoprolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Carvedilol (6.25 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Outcomes
Primary Outcome Measures
Dialytic Clearance
Dialytic clearance calculated by the recovery clearance method
Secondary Outcome Measures
Dialytic Clearance
Dialytic clearance calculated by the arteriovenous difference method
Full Information
NCT ID
NCT03361280
First Posted
November 21, 2017
Last Updated
November 27, 2017
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03361280
Brief Title
Removal of Beta Blocker Drugs by Hemodialysis
Official Title
Beta-blocker Dialyzability in Maintenance Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 27, 2015 (Actual)
Primary Completion Date
March 10, 2016 (Actual)
Study Completion Date
March 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol, bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood samples and spent dialysate are collected during dialysis. On separate dialysis sessions, patients received the other study drugs until they have taken each of the four study drugs. Dialytic clearance is calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
hemodialysis, dialytic clearance, pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atenolol
Arm Type
Experimental
Arm Description
Atenolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Arm Title
Bisoprolol
Arm Type
Experimental
Arm Description
Bisoprolol (5 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Arm Title
Metoprolol
Arm Type
Experimental
Arm Description
Metoprolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Carvedilol (6.25 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Intervention Type
Drug
Intervention Name(s)
Beta blocker
Intervention Description
Beta blockers are administered as described in arms.
Primary Outcome Measure Information:
Title
Dialytic Clearance
Description
Dialytic clearance calculated by the recovery clearance method
Time Frame
Through study completion, average of one year.
Secondary Outcome Measure Information:
Title
Dialytic Clearance
Description
Dialytic clearance calculated by the arteriovenous difference method
Time Frame
Through study completion, average of one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.
Exclusion Criteria:
gastrointestinal or liver disease, body mass index greater than 40 kg/m2, contraindications for receiving a beta blocker (treatment with contraindicated medications, prior adverse reaction, severe reactive airway disease, hemodynamic instability during dialysis).
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Plasma concentrations of beta blockers will be shared with other researchers if requested.
Learn more about this trial
Removal of Beta Blocker Drugs by Hemodialysis
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