Kidney DiseaseNCT01111266
Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)
A study testing xevonta in people with Kidney Disease, run by B.Braun Avitum AG at 1 site in Germany.
Trial summary
The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- What is being tested?
- xevonta
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from patient or parents/ guardian.
- Subject age >= 18
- Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
- On hemodialysis for a minimum of 3 months
- Use of Cimino- or Gore-tex shunts
- Routine dialysis-treatment for 240 min
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- Documented dialysis adequacy parameter that has been stable for past 3 months
- Plan to dialyze at participating hemodialysis centre for at least 3-months duration.
- Free from any currently known unusual clotting or access problems
- Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
- Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days
- Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days
- Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment
Who cannot join
- Patients who are unable to tolerate an effective blood flow of 350 ml/min
- Patients using catheter for dialysis
- Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
- Previous plan for extended absences from the participating hemodialysis centre
- Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD
The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.
- Conditions
- Kidney Disease
- Being tested
- xevonta
- Keywords
- in vivo KUF, ß2M, leptin
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xevontaDevice
Patients will be treated with 3 different sizes of xevonta (2 weeks each size) for determination of in vivo KUF following "FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers". In addition blood samples will be collected for determination of removal rates of different small molecules and protein.
What is being measured
The primary outcome is the main question the study is designed to answer.
in vivo KUF
The objective of this study is to to determine in vivo KUF for three different sizes (1.2; 1.8 and 2.3 m^2) of xevonta High-Flux to compare obtained data with respective in vitro KUF data.
Measured: 6 weeks
Secondary outcomes (1)
Determination of removal rates
Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.Braun Avitum AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labor Limbach, Heidelberg, Germany, Clin-Sol, Würzburg, Germany
- Responsible party
- Sponsor
- Investigators
- Jürgen Wagner, Prof. Dr., Study director, B.Braun Avitum AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111266
- Sponsor's protocol ID
- BA-I-H-09-02
- Status last verified
- Mar 2012
- First submitted
- 15 Apr 2010
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD
- ClinicalTrials.gov ID
- NCT01111266
- Acronym / sponsor ID
- BA-I-H-09-02
- Conditions
- Kidney Disease
- Keywords
- in vivo KUF, ß2M, leptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- B.Braun Avitum AGIndustry (pharma, biotech, devices)
- Collaborators
- Labor Limbach, Heidelberg, Germany, Clin-Sol, Würzburg, Germany
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Apr 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.
The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent obtained from patient or parents/ guardian.
- Subject age >= 18
- Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
- On hemodialysis for a minimum of 3 months
- Use of Cimino- or Gore-tex shunts
Key exclusion criteria (6 listed)
- Patients who are unable to tolerate an effective blood flow of 350 ml/min
- Patients using catheter for dialysis
- Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
- Previous plan for extended absences from the participating hemodialysis centre
- Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
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 |
|---|---|---|
| xevontaPatients will be treated with 3 different sizes of xevonta (2 weeks each size) for determination of in vivo KUF following "FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers". In addition blood samples will be collected for determination of removal rates of different small molecules and protein. | Device | – |
Primary outcome
in vivo KUF
Time frame: 6 weeks
The objective of this study is to to determine in vivo KUF for three different sizes (1.2; 1.8 and 2.3 m^2) of xevonta High-Flux to compare obtained data with respective in vitro KUF data.
1 secondary outcome
Determination of removal rates
Time frame: 6 weeks
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 2012.
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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.
Jürgen Wagner, Prof. Dr. study director
B.Braun Avitum AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xevonta in people with Kidney Disease, run by B.Braun Avitum AG at 1 site in Germany.
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 13 inclusion and 6 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 2012. 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 Germany. 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?
in vivo KUF (time frame: 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 2012.