InfluenzaNCT01146353
Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy
An observational study of Influenza and Renal Failure, run by Midwestern University at 1 site in United States.
Trial summary
Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Renal Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are male or female patients ≥18 years of age who are hospitalized, undergoing CVVH or CVVHD, and receiving peramivir. Eligible patients will additionally have the following: blood flow rate will be required to be ≥100 mL/ min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr, and the continuous renal replacement therapy must be scheduled to run for the full duration of the dosing interval (full 24 hours). Written informed consent in a form approved by the Northwestern University and the Midwestern University Institutional Review Boards will be granted by the patient.
Who may be able to join
- Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as a result of the clinical management of the patient (i.e. CRRT is not initiated for the purpose of this study).
- Patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of H1N1 disease.
- Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,
- The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours).
Who cannot join
- The patient has received greater than 5 doses of peramivir.
- The subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
- The patient is receiving CRRT utilizing a pre-membrane dilution method.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern University/Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.
Read the detailed description
This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.
- Conditions
- Influenza, Renal Failure
- Keywords
- peramivir, CVVH, CRRT, CVVHD, influenza, sieving coefficient, clearance
- Medical subject headings
- Influenza, Human, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRRT Patients receiving Peramivir | Eligible patients are male or female patients ≥18 years of age who are hospitalized, undergoing CVVH or CVVHD, and receiving peramivir. Eligible patients will additionally have the following: blood flow rate will be required to be ≥100 mL/ min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr, and the continuous renal replacement therapy must be scheduled to run for the full duration of the dosing interval (full 24 hours). Written informed consent in a form approved by the Northwestern University and the Midwestern University Institutional Review Boards will be granted by the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be to determine the sieving coefficient for peramivir.
Measured: upon study completion (estimated 2 yrs)
Secondary outcomes (1)
Determine the extracorporeal clearance for peramivir
Measured: upon study completion (estimated 2 yrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Peramivir EUA terminated by FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, BioCryst Pharmaceuticals
- Responsible party
- Principal investigator, Marc Scheetz, Midwestern University
- Investigators
- Marc H Scheetz, PharmD, MSc, Principal investigator, Midwestern University and Northwestern Memorial HospitalMichael Ison, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146353
- Sponsor's protocol ID
- STU00023343
- Status last verified
- Mar 2018
- First submitted
- 16 Jun 2010
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01146353
- Acronym / sponsor ID
- STU00023343
- Conditions
- Influenza, Renal Failure
- Keywords
- peramivir, CVVH, CRRT, CVVHD, influenza, sieving coefficient, clearance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Peramivir EUA terminated by FDA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, BioCryst Pharmaceuticals
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Jun 2010 (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.
Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.
Detailed description
This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRRT Patients receiving Peramivir | – | –Eligible patients are male or female patients ≥18 years of age who are hospitalized, undergoing CVVH or CVVHD, and receiving peramivir. Eligible patients will additionally have the following: blood flow rate will be required to be ≥100 mL/ min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr, and the continuous renal replacement therapy must be scheduled to run for the full duration of the dosing interval (full 24 hours). Written informed consent in a form approved by the Northwestern University and the Midwestern University Institutional Review Boards will be granted by the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are male or female patients ≥18 years of age who are hospitalized, undergoing CVVH or CVVHD, and receiving peramivir. Eligible patients will additionally have the following: blood flow rate will be required to be ≥100 mL/ min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr, and the continuous renal replacement therapy must be scheduled to run for the full duration of the dosing interval (full 24 hours). Written informed consent in a form approved by the Northwestern University and the Midwestern University Institutional Review Boards will be granted by the patient.
Key inclusion criteria (4 listed)
- Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as a result of the clinical management of the patient (i.e. CRRT is not initiated for the purpose of this study).
- Patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of H1N1 disease.
- Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,
- The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours).
Key exclusion criteria (3 listed)
- The patient has received greater than 5 doses of peramivir.
- The subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
- The patient is receiving CRRT utilizing a pre-membrane dilution method.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure will be to determine the sieving coefficient for peramivir.
Time frame: upon study completion (estimated 2 yrs)
1 secondary outcome
Determine the extracorporeal clearance for peramivir
Time frame: upon study completion (estimated 2 yrs)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
Marc H Scheetz, PharmD, MSc principal investigator
Midwestern University and Northwestern Memorial Hospital
Michael Ison, MD principal investigator
Northwestern 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 Influenza and Renal Failure, run by Midwestern 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Mar 2018. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary outcome measure will be to determine the sieving coefficient for peramivir. (time frame: upon study completion (estimated 2 yrs)). 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 20 Mar 2018.