Kidney Failure,ChronicNCT02964429
Determination In-vivo KUF for Diacap Pro Hemodialyser
A study testing Diacap Pro High-Flux in people with Kidney Failure,Chronic and Renal Insufficiency,Chronic, run by B.Braun Avitum AG at 1 site in Czechia.
Trial summary
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure,Chronic, Renal Insufficiency,Chronic, Kidney Disease, End-Stage
- What is being tested?
- Diacap Pro High-Flux
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Nov 2016to 23 Dec 2016
- 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 in the range of 500 - 800 ml/min
- On hemodialysis for a minimum of 3 months
- Use of Cimino- or Gore-tex shunts
- Routine dialysis-treatment for 240 min and 3 times per week
Show all 12Show fewer
- Documented dialysis adequacy parameter spKt/V >=1.2 that has been stable for past 3 months
- Plan to dialyze at participating hemodialysis center 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 HCV negative, documented within the past 90 days
- Anti HIV negative, documented within the past 90 days Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL
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
- 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: Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
Read the detailed description
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.
Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
- Conditions
- Kidney Failure,Chronic, Renal Insufficiency,Chronic, Kidney Disease, End-Stage, Kidney Insufficiency
- Being tested
- Diacap Pro High-Flux
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacap Pro High-FluxDevice
During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF.
| Study group | Role | What they receive |
|---|---|---|
| Diacap Pro High-Flux | Experimental | 1.3/ 1.6/ 1.9 sqm Receives: Device: Diacap Pro High-Flux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented.
Measured: For two of three dialysis sessions each week for a total study period of six weeks
Secondary outcomes (8)
Clearance data dialyzer [ml/min]
For ß2M; Myoglobin; Retinol-Binding-Protein; alpha-1-Microglobulin; Albumin clearance data will be assessed by using serum samples pre- and post dialyzer at timepoints t=0 and t=240 min.
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Reduction rates dialyzer [%]
For urea; creatinine; phosphate; ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein; alpha-1 Microglobulin and Albumin reduction rates will be calculated by using serum-levels at timepoints t=0 and t=240 min.
Measured: For two of three dialysis sessions each week for a total study period of six weeks
Total removal of proteins [mg/session]
Spent dialysate will be collected during the entire dialysis treatment. Considering dialysate flow rate and ultrafiltration volume concentration of ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein;alpha-1 Microglobulin; Albumin; Total Protein will be used to calculate total removal by multiplying with the effective spent dialysate volume
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation C3a and C5a [ng/ml]
For complement activation C3a [ng/ml]; C5a [ng/ml] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation TAT III [µg/l]
For complement activation TAT III [µg/l] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
For inflammatory response Interleukin-1 [pg/ml]; Interleukin-6 [pg/ml]; TNF-alpha will be assessed at timepoints t=0; t=15; t=60; t=240 min
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response CRP [mg/l]
For inflammatory response CRP[mg/l] will be assessed at timepoints t=0; t=15; t=60; t=240 min
Measured: For one of six dialysis sessions each two weeks for a total study period of six weeks
Incidence of Treatment-Emergent Adverse Events
Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading.
Measured: November 2016 up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start14 Nov 2016
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure,ChronicStudies 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
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Vladimir Polakovic, Prim. MUDr., Principal investigator, Interni oddeleni Strahov VFN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964429
- Sponsor's protocol ID
- BA-G-H-1602
- Status last verified
- Feb 2017
- First submitted
- 28 Oct 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT02964429
- Acronym / sponsor ID
- BA-G-H-1602
- Conditions
- Kidney Failure,Chronic, Renal Insufficiency,Chronic, Kidney Disease, End-Stage, Kidney Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- B.Braun Avitum AGIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 16 Nov 2016 (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 main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
Detailed description
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.
Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diacap Pro High-Flux | Experimental | Device: Diacap Pro High-Flux1.3/ 1.6/ 1.9 sqm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent obtained from patient or parents/ guardian.
- Subject age > 18
- Effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 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
- 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 |
|---|---|---|
| Diacap Pro High-FluxDuring dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF. | Device | Diacap Pro High-Flux |
Primary outcome
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
Time frame: For two of three dialysis sessions each week for a total study period of six weeks
UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented.
8 secondary outcomes
Clearance data dialyzer [ml/min]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Reduction rates dialyzer [%]
Time frame: For two of three dialysis sessions each week for a total study period of six weeks
Total removal of proteins [mg/session]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation C3a and C5a [ng/ml]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation TAT III [µg/l]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response CRP [mg/l]
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: November 2016 up to 2 months
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 7 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Vladimir Polakovic, Prim. MUDr. principal investigator
Interni oddeleni Strahov VFN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacap Pro High-Flux in people with Kidney Failure,Chronic and Renal Insufficiency,Chronic, run by B.Braun Avitum AG at 1 site in Czechia.
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 12 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 7 Feb 2017. 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 Czechia. 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?
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF) (time frame: For two of three dialysis sessions each week for a total study period of six 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 7 Feb 2017.