Kidney FailureTAGPSOLACEANCT02546037
Clotting With Different Dialyzer Membranes
An observational study of Kidney Failure, run by University College, London.
Trial summary
Primary Objective: The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment. 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?
- FX100 dialyzer and SOLACEA 21H
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2016to 30 Jul 2017
- 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: attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney disease
Who may be able to join
- Patients age 18 years and older up to 80 years
- Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
- Able to provide written informed consent obtained
Who cannot join
- Patients scheduled for a kidney transplant
- Patients taking concomitant systemic anticoagulants
- Patients with known prothrombotic or bleeding disorders
- Patients with abnormal platelet counts
- Patients unable to provide written informed consent
- Patients not fulfilling inclusion criteria
About this study
Official title: Pilot Study to Determine the Effect of Different Dialyzer Membranes on Clotting During Haemodiafiltration Treatments in Patients With Chronic Kidney Disease
Primary Objective:
The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.
Read the detailed description
This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.
- Conditions
- Kidney Failure
- Being tested
- FX100 dialyzer, SOLACEA 21H
- Keywords
- coagulation, haemodialysis
- Medical subject headings
- Renal Insufficiency, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX100 dialyzerDevice
Also called Fresenius FX 100
comparison of dialyzers
SOLACEA 21HDevice
comparison of dialyzers
| Study group | Role | What they receive |
|---|---|---|
| SOLACEA 21H | single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan) Receives: Device: SOLACEA 21H | |
| FX100 | single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany) Receives: Device: FX100 dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
convective volume exchanged
volume of convective exchange achieved during the HDF session
Measured: day 1
Secondary outcomes (3)
platelet and coagulation pathway activation
measurement of coagulation pathway proteins and platelet activation markers
Measured: day 1
visual coagulation
visual analogue score assessment of clotting in the extracorporeal circuit
Measured: day 1
small and middle sized solute clearances
dialyzer clearance of small and middle sized molecules, including urea and beta 2 microglobulin
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start30 Sep 2016
- Primary completion30 May 2017
- Study completion30 Jul 2017
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 University College, LondonThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- andrew davenport, Principal investigator, UCL centre for nephrology, Royal Free Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546037
- Sponsor's protocol ID
- REC: 08/H0724/11
- Acronym
- TAGPSOLACEA
- Status last verified
- Oct 2018
- First submitted
- 11 Aug 2015
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Effect of Different Dialyzer Membranes on Clotting During Haemodiafiltration Treatments in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02546037
- Acronym / sponsor ID
- TAGPSOLACEA / REC: 08/H0724/11
- Conditions
- Kidney Failure
- Keywords
- coagulation, haemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 10 Sep 2015 (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.
Primary Objective:
The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.
Detailed description
This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOLACEA 21H | – | Device: SOLACEA 21Hsingle haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan) |
| FX100 | – | Device: FX100 dialyzersingle haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney disease
Key inclusion criteria (3 listed)
- Patients age 18 years and older up to 80 years
- Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
- Able to provide written informed consent obtained
Key exclusion criteria (6 listed)
- Patients scheduled for a kidney transplant
- Patients taking concomitant systemic anticoagulants
- Patients with known prothrombotic or bleeding disorders
- Patients with abnormal platelet counts
- Patients unable to provide written 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 |
|---|---|---|
| FX100 dialyzerAlso: Fresenius FX 100comparison of dialyzers | Device | FX100 |
| SOLACEA 21Hcomparison of dialyzers | Device | SOLACEA 21H |
Primary outcome
convective volume exchanged
Time frame: day 1
volume of convective exchange achieved during the HDF session
3 secondary outcomes
platelet and coagulation pathway activation
Time frame: day 1
visual coagulation
Time frame: day 1
small and middle sized solute clearances
Time frame: day 1
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 23 Oct 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.
andrew davenport principal investigator
UCL centre for nephrology, Royal Free Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by University College, London.
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 3 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 23 Oct 2018. 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?
convective volume exchanged (time frame: day 1). 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 23 Oct 2018.