Removal of Beta Blocker Drugs by Hemodialysis

NCT03361280 | Completed Phase 1

• 1 other identifier: 104909
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Diseases

Keywords

hemodialysis; dialytic clearance; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Dialytic Clearance

  Dialytic clearance calculated by the recovery clearance method

  Through study completion, average of one year.

Secondary Outcomes (1)

• Dialytic Clearance

  Through study completion, average of one year.

Study Arms (4)

Atenolol

EXPERIMENTAL

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.

Drug: Beta blocker

Bisoprolol

EXPERIMENTAL

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.

Drug: Beta blocker

Metoprolol

EXPERIMENTAL

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.

Drug: Beta blocker

Carvedilol

EXPERIMENTAL

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.

Drug: Beta blocker

Interventions

Beta blocker DRUG

Beta blockers are administered as described in arms.

Atenolol; Bisoprolol; Carvedilol; Metoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.

You may not qualify if:

• 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).

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 4, 2017
• Study Start: February 27, 2015
• Primary Completion: March 10, 2016
• Study Completion: March 10, 2016
• Last Updated: December 4, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share