Peritoneal Dialysis-associated PeritonitisPhase 1NCT03685747
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
A Phase 1 study testing Vancomycin in people with Peritoneal Dialysis-associated Peritonitis, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 1 Oct 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or females between 18 - 85 years old
- Stabilized on a PD regimen for > 3 months prior to study initiation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis
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.
Read the detailed description
Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis.
Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF.
The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities.
- Being tested
- Vancomycin
- Keywords
- Vancomycin, Pharmacokinetics, Pharmacodynamics, Automated Peritoneal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin one-time 20 mg/kg intraperitoneal dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Total Plasma Concentration (Cmax)
Total systemic plasma concentration following 12-hour dwell
Measured: Day: 1
Time to Maximum Plasma Concentration (Tmax)
Time (hours) to achieve the maximum plasma concentration
Measured: Day: 1
Area Under the Concentration-time Curve (AUC0-inf)
AUC based on vancomycin plasma concentrations
Measured: Days: 1-7
Total Body Clearance (CLtotal)
Total vancomycin plasma vancomycin clearance
Measured: Days: 1-7
Dialytic Clearance
Vancomycin clearance from peritoneal dialysis
Measured: Days: 1-7
Secondary outcomes (1)
Adverse Events
Any adverse events throughout entirety of study as assessed by physician-investigator
Measured: Days: 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start15 Nov 2018
- Primary completion30 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter K. Kraft, Thomas Jefferson University
- Investigators
- Walter K Kraft, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685747
- Sponsor's protocol ID
- 12451
- Status last verified
- Mar 2022
- First submitted
- 25 Sep 2018
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual level PK de-identified data maybe shared
Publications
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.
PubMed 34755479
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03685747
- Acronym / sponsor ID
- 12451
- Keywords
- Vancomycin, Pharmacokinetics, Pharmacodynamics, Automated Peritoneal Dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis.
Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF.
The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: VancomycinA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male or females between 18 - 85 years old
- Stabilized on a PD regimen for > 3 months prior to study initiation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinVancomycin one-time 20 mg/kg intraperitoneal dose. | Drug | Vancomycin |
Primary outcome
Maximum Total Plasma Concentration (Cmax)
Time frame: Day: 1
Total systemic plasma concentration following 12-hour dwell
Time to Maximum Plasma Concentration (Tmax)
Time frame: Day: 1
Time (hours) to achieve the maximum plasma concentration
Area Under the Concentration-time Curve (AUC0-inf)
Time frame: Days: 1-7
AUC based on vancomycin plasma concentrations
Total Body Clearance (CLtotal)
Time frame: Days: 1-7
Total vancomycin plasma vancomycin clearance
Dialytic Clearance
Time frame: Days: 1-7
Vancomycin clearance from peritoneal dialysis
1 secondary outcome
Adverse Events
Time frame: Days: 1-7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34755479Lam 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.
- Individual participant dataSharing planned: Yes. Individual level PK de-identified data maybe shared
Related trials for Peritoneal Dialysis-associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter K Kraft, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin in people with Peritoneal Dialysis-associated Peritonitis, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Total Plasma Concentration (Cmax) (time frame: Day: 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.