Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

NCT03685747 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 12451
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.

Conditions

Peritoneal Dialysis-associated Peritonitis

Keywords

Vancomycin; Pharmacokinetics; Pharmacodynamics; Automated Peritoneal Dialysis

Outcome Measures

Primary Outcomes (5)

• Maximum Total Plasma Concentration (Cmax)

  Total systemic plasma concentration following 12-hour dwell

  Day: 1

• Time to Maximum Plasma Concentration (Tmax)

  Time (hours) to achieve the maximum plasma concentration

  Day: 1

• Area Under the Concentration-time Curve (AUC0-inf)

  AUC based on vancomycin plasma concentrations

  Days: 1-7

• Total Body Clearance (CLtotal)

  Total vancomycin plasma vancomycin clearance

  Days: 1-7

• Dialytic Clearance

  Vancomycin clearance from peritoneal dialysis

  Days: 1-7

Secondary Outcomes (1)

• Adverse Events

  Days: 1-7

Study Arms (1)

Vancomycin

EXPERIMENTAL

A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.

Drug: Vancomycin

Interventions

Vancomycin DRUG

Vancomycin one-time 20 mg/kg intraperitoneal dose.

Vancomycin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or females between 18 - 85 years old
• Stabilized on a PD regimen for \> 3 months prior to study initiation

You may not qualify if:

• Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator
• Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution
• Active peritonitis infection
• Previous intraperitoneal antibiotic treatment within 2 months
• Previous intravenous vancomycin treatment within 2 months
• Hemoglobin \< 9 g/dL
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Lam E, Ting Kayla Lien Y, Kraft WK, Stickle DF, Piraino B, Zhang J. Intraperitoneal pharmacokinetics of vancomycin in patients on automated peritoneal dialysis. Clin Transl Sci. 2022 Mar;15(3):649-657. doi: 10.1111/cts.13182. Epub 2021 Nov 9.

  PMID: 34755479 RESULT

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Walter Kraft
• Organization: Thomas Jefferson University

walter.kraft@jefferson.edu

2159559077

Study Officials

• Walter K Kraft, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Unit Medical Director

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: November 15, 2018
• Primary Completion: August 30, 2020
• Study Completion: October 1, 2020
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: through 2024
• Access Criteria: email. walter.kraft@jefferson.edu

Locations

US (1)