Renal FailureLZDPPT6NCT02087566
Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)
A study testing 600 mg linezolid in people with Renal Failure and Impaired Renal Function, run by Damanhour University.
Trial summary
Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged… Read more about this study
- Who is it for?
- Ages 22 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Failure, Impaired Renal Function
- What is being tested?
- 600 mg linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2014
- Phase
- Interventional
- 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 22 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with normal renal function (CLcr ˃80 ml/min);
- Patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)
- Patients on long term HD with an ideal body weight of >60 kg and a body mass index between 20 and 26 kg/m2
- Passed all the screening parameters
- Free of any drug exposure known to interfere with the pharmacokinetics or assay of linezolid for at least 10 days prior to the study
- Able to communicate effectively with study personnel, be literate, and able to give consent.
Who cannot join
- Had a history of clinically significant organ dysfunction other than renal disease or those diseases associated with renal disease (as in case of acute RF or ESRD patients) Had physical examination or laboratory test results outside the inclusion such as; sitting systolic BP (SBP) of >140 or <100 mmHg, diastolic BP (DBP) > 90 or <60mm Hg (as in case of healthy volunteers and acute RF patients), or a pulse rate of > 95 or < 50 beats/min at screening; history of orthostatic hypotension; history of serious intolerance, allergy or sensitivity to linezolid ; history of blood dyscrasias; history of alcohol, smoking, or drug abuse; donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study; unable to tolerate vein puncture and multiple blood samplings; any surgical/medical condition that might alter the absorption, distribution, metabolism, excretion of linezolid ; or can't follow instructions, according to the investigator's opinion.
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About this study
Official title: Single-Dose Linezolid Pharmacokinetics In Critically Ill Patients With Impaired Renal Function Especially Chronic Haemodialysis Patients
Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged in urine.
- Conditions
- Renal Failure, Impaired Renal Function
- Being tested
- 600 mg linezolid
- Keywords
- Linezolid, Pharmacokinetics, Haemodialysis, Dosing adjustment, Eligible subjects were classified into three groups depending on their 24-h urinary creatinine clearance (CLcr) values or HD status., Group 1, included 6 healthy subjects with normal renal function (CLcr ˃80 ml/min);, Group 2, included 6 patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine);, Group 3, included 6 patients on long term haemodialysis (minimum period of dialysis was 40 month while maximum period were 130 month)
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg linezolidDrug
| Study group | Role | What they receive |
|---|---|---|
| Administration of linezolid to 6 healthy volunteers | Other | Administration of linezolid to 6 healthy volunteers {six healthy subjects with normal renal function (CLcr ˃80 ml/min)} Receives: Drug: 600 mg linezolid |
| Administration of linezolid to 6 acute renal failure patients | Other | Administration of linezolid to 6 acute renal failure patients {(six patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)} Receives: Drug: 600 mg linezolid |
| Administration of linezolid to 6 ESRD patients | Other | Administration of linezolid to 6 end-stage renal disease (ESRD) patients during an intra-dialytic period (on-dialysis): 6 patients on long term HD (minimum period of dialysis was 40 month while maximum period were 130 month) with an ideal body weight of >60 kg (calculated as {height (cm) -100}×0.9) and a body mass index between 20 and 26 kg/m2 (calculated as {weight (kg)/height (m2)}). Receives: Drug: 600 mg linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.
Measured: Participants will be followed for the duration of study, an expected average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Helmy, PhD, CPHQ, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087566
- Sponsor's protocol ID
- LZDPPT6
- Acronym
- LZDPPT6
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Linezolid Pharmacokinetics In Critically Ill Patients With Impaired Renal Function Especially Chronic Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT02087566
- Acronym / sponsor ID
- LZDPPT6 / LZDPPT6
- Conditions
- Renal Failure, Impaired Renal Function
- Keywords
- Linezolid, Pharmacokinetics, Haemodialysis, Dosing adjustment, Eligible subjects were classified into three groups depending on their 24-h urinary creatinine clearance (CLcr) values or HD status., Group 1, included 6 healthy subjects with normal renal function (CLcr ˃80 ml/min);, Group 2, included 6 patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine);, Group 3, included 6 patients on long term haemodialysis (minimum period of dialysis was 40 month while maximum period were 130 month)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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.
Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged in urine.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of linezolid to 6 healthy volunteers | Other | Drug: 600 mg linezolidAdministration of linezolid to 6 healthy volunteers {six healthy subjects with normal renal function (CLcr ˃80 ml/min)} |
| Administration of linezolid to 6 acute renal failure patients | Other | Drug: 600 mg linezolidAdministration of linezolid to 6 acute renal failure patients {(six patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)} |
| Administration of linezolid to 6 ESRD patients | Other | Drug: 600 mg linezolidAdministration of linezolid to 6 end-stage renal disease (ESRD) patients during an intra-dialytic period (on-dialysis): 6 patients on long term HD (minimum period of dialysis was 40 month while maximum period were 130 month) with an ideal body weight of >60 kg (calculated as {height (cm) -100}×0.9) and a body mass index between 20 and 26 kg/m2 (calculated as {weight (kg)/height (m2)}). |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects with normal renal function (CLcr ˃80 ml/min);
- Patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)
- Patients on long term HD with an ideal body weight of >60 kg and a body mass index between 20 and 26 kg/m2
- Passed all the screening parameters
- Free of any drug exposure known to interfere with the pharmacokinetics or assay of linezolid for at least 10 days prior to the study
Key exclusion criteria (2 listed)
- Had a history of clinically significant organ dysfunction other than renal disease or those diseases associated with renal disease (as in case of acute RF or ESRD patients) Had physical examination or laboratory test results outside the inclusion such as; sitting systolic BP (SBP) of >140 or <100 mmHg, diastolic BP (DBP) > 90 or <60mm Hg (as in case of healthy volunteers and acute RF patients), or a pulse rate of > 95 or < 50 beats/min at screening; history of orthostatic hypotension; history of serious intolerance, allergy or sensitivity to linezolid ; history of blood dyscrasias; history of alcohol, smoking, or drug abuse; donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study; unable to tolerate vein puncture and multiple blood samplings; any surgical/medical condition that might alter the absorption, distribution, metabolism, excretion of linezolid ; or can't follow instructions, according to the investigator's opinion.
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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 |
|---|---|---|
| 600 mg linezolid | Drug | Administration of linezolid to 6 ESRD patients, Administration of linezolid to 6 acute renal failure patients, Administration of linezolid to 6 healthy volunteers |
Primary outcome
Tolerability
Time frame: Participants will be followed for the duration of study, an expected average of 6 weeks.
Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.
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 14 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 600 mg linezolid in people with Renal Failure and Impaired Renal Function, run by Damanhour University.
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 6 inclusion and 2 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Tolerability (time frame: Participants will be followed for the duration of study, an expected average of 6 weeks.). 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 14 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.