Kidney FailureNCT03714789
Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy
An observational study of Kidney Failure, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Blood and spent dialysate collection
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients aged from 18 to 85 years, requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai, China.
Who may be able to join
- With Age from 18 to 85 years old.
- With weight from 50 to 75 kilograms.
- Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
- Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.
Who cannot join
- Patient is during pregnant or lactation period.
- Patient is allergic to meropenem, vancomycin or ceftriaxone.
- Severe hypoproteinemia (serum total protein<=45g/L) or severe hypoalbuminemia（serum albumin<20g/L).
- Severe liver dysfunction（ALT>200U/L or AST>200U/L).
- The patient himself or his immediate family refuses to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clearance and Pharmacokinetics of Antibiotics With Different Protein-bound Levels in Renal Replacement Therapy
This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
Read the detailed description
This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
- Conditions
- Kidney Failure
- Being tested
- Blood and spent dialysate collection
- Keywords
- Kidney Failure, Pharmacokinetics, Antibiotics
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and spent dialysate collectionOther
A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Patients requiring dialysis and receiving meropenem for infection or suspended infection. Receives: Other: Blood and spent dialysate collection | |
| Vancomycin | Patients requiring dialysis and receiving vancomycin for infection or suspended infection. Receives: Other: Blood and spent dialysate collection | |
| Ceftriaxone | Patients requiring dialysis and receiving ceftriaxone for infection or suspended infection. Receives: Other: Blood and spent dialysate collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialytic clearance (K_total)
The total drug amount removed by dialysis
Measured: During the session of dialysis, up to 4 hours
Area under the concentration-time curve (AUC)
AUC based on plasma concentration during dialysis
Measured: During the session of dialysis, up to 4 hours
Secondary outcomes (1)
Rebound of plasma concentration (Rebound_1h%)
The rebound rate of plasma concentration 1 hour after dialysis
Measured: At the end of dialysis and an hour after dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Nov 2017
- Primary completion30 Dec 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Antibiotics, Huashan Hospital, Fudan University
- Responsible party
- Principal investigator, Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Feng Ding, PhD, Study director, Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714789
- Sponsor's protocol ID
- PKDialysis-201710
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2018
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance and Pharmacokinetics of Antibiotics With Different Protein-bound Levels in Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03714789
- Acronym / sponsor ID
- PKDialysis-201710
- Conditions
- Kidney Failure
- Keywords
- Kidney Failure, Pharmacokinetics, Antibiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Institute of Antibiotics, Huashan Hospital, Fudan University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
Detailed description
This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meropenem | – | Other: Blood and spent dialysate collectionPatients requiring dialysis and receiving meropenem for infection or suspended infection. |
| Vancomycin | – | Other: Blood and spent dialysate collectionPatients requiring dialysis and receiving vancomycin for infection or suspended infection. |
| Ceftriaxone | – | Other: Blood and spent dialysate collectionPatients requiring dialysis and receiving ceftriaxone for infection or suspended infection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged from 18 to 85 years, requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai, China.
Key inclusion criteria (4 listed)
- With Age from 18 to 85 years old.
- With weight from 50 to 75 kilograms.
- Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
- Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.
Key exclusion criteria (5 listed)
- Patient is during pregnant or lactation period.
- Patient is allergic to meropenem, vancomycin or ceftriaxone.
- Severe hypoproteinemia (serum total protein<=45g/L) or severe hypoalbuminemia（serum albumin<20g/L).
- Severe liver dysfunction（ALT>200U/L or AST>200U/L).
- The patient himself or his immediate family refuses to sign the informed consent.
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 |
|---|---|---|
| Blood and spent dialysate collectionA certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration. | Other | Ceftriaxone, Meropenem, Vancomycin |
Primary outcome
Dialytic clearance (K_total)
Time frame: During the session of dialysis, up to 4 hours
The total drug amount removed by dialysis
Area under the concentration-time curve (AUC)
Time frame: During the session of dialysis, up to 4 hours
AUC based on plasma concentration during dialysis
1 secondary outcome
Rebound of plasma concentration (Rebound_1h%)
Time frame: At the end of dialysis and an hour after dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Feng Ding, PhD study director
Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 4 inclusion and 5 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 26 Oct 2020. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dialytic clearance (K_total) (time frame: During the session of dialysis, up to 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2020.