Chronic Kidney Disease Requiring Chronic DialysisNCT03105817
Cellulose Triacetate Dialyzer in Hemodiafiltration-online
A study testing Asymmetric cellulose triacetate (ATA™) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
Trial summary
In post-dilution haemodiafiltration only synthetic membranes have been used to date. The allergy problems described with these membranes require the development of other membranes capable of performing this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Asymmetric cellulose triacetate (ATA™)
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2016to 14 Aug 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
- Criteria:being over 18 years old, being treated with OLHDF for more than 4 weeks with 3 weekly sessions and sign an informed consent form.
Who cannot join
- pregnancy and illness that would make the patient's death predictable in less than 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Cellulose Triacetate Dialyzer (Solacea™): in Vivo Behavior in Hemodiafiltration-online
In post-dilution haemodiafiltration only synthetic membranes have been used to date.
The allergy problems described with these membranes require the development of other membranes capable of performing this treatment. We describe in vivo performance and behaviour of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility in a single haemodialysis session (acute biocompatibility) and after one month of treatment (chronic).
Read the detailed description
An interventional study was performed in 3 hemodialysis hospital units (La Princesa University Hospital, Príncipe de Asturias University Hospital and Infanta Leonor University Hospital, Community of Madrid, Spain) in which the usual dialyzer that each patient had for OLHDF was replaced with the Solacea™ dialyzer keeping the rest of the parameters unchanged. The study (LIB 09/2015) was reviewed and approved by the CEIC of the Príncipe de Asturias University Hospital.
- Design of the study Each patient underwent 12 sessions of haemodialysis with the usual schedule and monitor: 5008 of Fresenius (n=14), AK200US (n=5) and Artis of Gambro (n=3) and DBB007 of Nikkiso (n=1) all suitable for OLHDF, although with different convective transport control systems. The nursing staff connected the automatic OLHDF system. In the case where the system was Ultracontrol® (Gambro monitors) if alarm of PTM> 300 mmHg or system pressure (PSist)> 700 mmHg appeared and were not solved, Ultracontrol® would be withdrawn and the pressure-control system would be used.
- Data to be collected:
- Demographic and dialysis data
- Demographic: sex, age, underlying disease, time in OLHDF, type of vascular access: fistula (AFV) and catheter (CT).
- Dialysis Data: Monitor, dialysis fluid composition, sodium conductivity and bicarbonate concentration, dialysis fluid flow (Qd, ml min), liquid temperature, heparin type and dosage.
- Each dialysis session: effective time (TE, min), blood flow (Qb, ml min), ultra-filtrated volume to achieve dry weight (UF, l/session), Vinf (l/session), infusion rate, (Qi, ml/min) Kt (l / session), maximum PTM and maximum Psist in Ultracontrol® (mmHg) and the technical complications, alarms and coagulation problems of the system that may appear. The filtration fraction (FF) was calculated as the percentage of Qi relative to Qb. The convective volume (Vconv) was defined as the total ultra-filtrated volume, which is the sum of VI and UF.7
- Analytical determinations
- Blood
- On the first and last day of the study pre-dialysis samples were taken for the measurement of monocytes, IL-6 and IL-1β.
- On the interval day of the first week, 3 blood samples were taken: 1st) at the beginning (CI), 2nd) at 30 min (CM) and the 3rd) at the end of the dialysis session (CP). In CI and CP the following parameters were measured: haemoglobin, proteins and albumin, urea, phosphorus, creatinine, uric acid, β2-microglobulin, myoglobin and retinol transport protein (RTP). Leukocytes, platelets, C3a and C5a were quantified in CI and CM. --- Laboratory determinations
- General biochemical data: haemoglobin, proteins, albumin, urea, phosphorus, reactive protein C (PCR), creatinine and uric acid, β2-microglobulin, myoglobin, and (RTP) were determined with the usual analyser of each hospital.
- Determinations of monocytes, complement, IL-6 and IL-1β were performed in the laboratory of the University of Alcalá:
- Activation of plasma complement using a sandwich ELISA: Determination of C3a and C5a activation was performed on platelet rich plasma samples using commercially available ELISA kits C3a Elabscience (Wuhan, P.R. China) and ELISA C5a RayBiotech (Norcross, Georgia).
- Determination of interleukin concentration in serum using a sandwich ELISA: IL-6 and IL-1β concentrations were measured in serum samples obtained from whole blood and stored at -80 ° C until use. Both kits used were supplied by Abcam (Cambridge, UK)
- Determination of monocyte subpopulations: The different subpopulations of circulating monocytes in peripheral blood were identified by flow cytometry (FACSCalibur™, Becton Dickinson, San Jose, CA, USA). First of all, the monocyte population was selected according to size (FSC/forward scatter) and granularity (SSC/side scatter) and then the different subpopulations were selected by double immunofluorescence according to staining with the anti-CD14 conjugated Tricolor (monoclonal antibodies TuK4) and anti-CD16 conjugated FITC (monoclonal antibodies 3G8). Both antibodies and their respective isotype controls were purchased from Life Technologies Invitrogen (California, USA). The analysis was performed with the Cyflogic program.
- Calculations The percentages of reduction (RR) were calculated with the formula: RR (%) = [(Cpre - Cpos) / Cpre] x 100, where Cpre and Cpos are the concentrations of the analysed substances pre- and post-dialysis. For protein bound substances and β2-microglobulin concentrations at the end of the session were corrected for haemoconcentration by a correction factor (FC) based on plasma protein concentration (PT): FC = PTpre / PTpos, where PTpre and PTpos are the total concentration of proteins pre-dialysis and post-dialysis. --- Statistical analysis All data was collected in a database (SPSS version 15). Each value was obtained with the average of the values obtained in the different sessions or analytical determinations. For the statistical analysis, descriptive tools were used, showing the average (standard deviation), median, quartiles or percentages as appropriate. For the comparison of two independent continuous variables, the Student t test for paired samples was used. For the comparison of more than two quantitative variables the ANOVA test was used. The p <0.05 was considered statistically significant.
- Being tested
- Asymmetric cellulose triacetate (ATA™)
- Keywords
- Asymmetric cellulose triacetate, Biocompatibility, Hemodiafiltration on-line, Convective volume, Adequacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetric cellulose triacetate (ATA™)Device
Also called Solacea™
Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of asymmetric cellulose triacetate (ATA™)
Describing in vivo depurative efficacy of asymmetric cellulose triacetate (ATA™) measuring Kt, infusion volumen and clearance of RR of different molecules
Measured: One month
Biocompatibility of asymmetric cellulose triacetate (ATA™)
Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)
Measured: One month
Clinical behaviour of ATA
Studuying alarm or clínical problemas related with dialyzer
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Feb 2016
- Primary completion10 Jul 2016
- Study completion14 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105817
- Sponsor's protocol ID
- LIB 09/2015
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maduell F, Navarro V, Hernandez-Jaras J, Calvo C. [Comparison of dialyzers in on-line hemodiafiltration]. Nefrologia. 2000 May-Jun;20(3):269-76. Spanish.
PubMed 10917004Sunohara T, Masuda T. Fundamental Characteristics of the Newly Developed ATA Membrane Dialyzer. Contrib Nephrol. 2017;189:215-221. doi: 10.1159/000451044. Epub 2016 Dec 12.
PubMed 27951571Sanchez-Villanueva RJ, Gonzalez E, Quirce S, Diaz R, Alvarez L, Menendez D, Rodriguez-Gayo L, Bajo MA, Selgas R. Hypersensitivity reactions to synthetic haemodialysis membranes. Nefrologia. 2014;34(4):520-5. doi: 10.3265/Nefrologia.pre2014.May.12552. English, Spanish.
PubMed 25036066Mineshima M. Optimal Design of Dialyzers. Contrib Nephrol. 2017;189:204-209. doi: 10.1159/000450802. Epub 2016 Dec 12.
PubMed 27951569Sunohara T, Masuda T. Cellulose triacetate as a high-performance membrane. Contrib Nephrol. 2011;173:156-163. doi: 10.1159/000329055. Epub 2011 Aug 8.
PubMed 21865788
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cellulose Triacetate Dialyzer (Solacea™): in Vivo Behavior in Hemodiafiltration-online
- ClinicalTrials.gov ID
- NCT03105817
- Acronym / sponsor ID
- LIB 09/2015
- Keywords
- Asymmetric cellulose triacetate, Biocompatibility, Hemodiafiltration on-line, Convective volume, Adequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 14 Aug 2016 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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.
In post-dilution haemodiafiltration only synthetic membranes have been used to date.
The allergy problems described with these membranes require the development of other membranes capable of performing this treatment. We describe in vivo performance and behaviour of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility in a single haemodialysis session (acute biocompatibility) and after one month of treatment (chronic).
Detailed description
An interventional study was performed in 3 hemodialysis hospital units (La Princesa University Hospital, Príncipe de Asturias University Hospital and Infanta Leonor University Hospital, Community of Madrid, Spain) in which the usual dialyzer that each patient had for OLHDF was replaced with the Solacea™ dialyzer keeping the rest of the parameters unchanged. The study (LIB 09/2015) was reviewed and approved by the CEIC of the Príncipe de Asturias University Hospital.
- Design of the study Each patient underwent 12 sessions of haemodialysis with the usual schedule and monitor: 5008 of Fresenius (n=14), AK200US (n=5) and Artis of Gambro (n=3) and DBB007 of Nikkiso (n=1) all suitable for OLHDF, although with different convective transport control systems. The nursing staff connected the automatic OLHDF system. In the case where the system was Ultracontrol® (Gambro monitors) if alarm of PTM> 300 mmHg or system pressure (PSist)> 700 mmHg appeared and were not solved, Ultracontrol® would be withdrawn and the pressure-control system would be used.
- Data to be collected:
- Demographic and dialysis data
- Demographic: sex, age, underlying disease, time in OLHDF, type of vascular access: fistula (AFV) and catheter (CT).
- Dialysis Data: Monitor, dialysis fluid composition, sodium conductivity and bicarbonate concentration, dialysis fluid flow (Qd, ml min), liquid temperature, heparin type and dosage.
- Each dialysis session: effective time (TE, min), blood flow (Qb, ml min), ultra-filtrated volume to achieve dry weight (UF, l/session), Vinf (l/session), infusion rate, (Qi, ml/min) Kt (l / session), maximum PTM and maximum Psist in Ultracontrol® (mmHg) and the technical complications, alarms and coagulation problems of the system that may appear. The filtration fraction (FF) was calculated as the percentage of Qi relative to Qb. The convective volume (Vconv) was defined as the total ultra-filtrated volume, which is the sum of VI and UF.7
- Analytical determinations
- Blood
- On the first and last day of the study pre-dialysis samples were taken for the measurement of monocytes, IL-6 and IL-1β.
- On the interval day of the first week, 3 blood samples were taken: 1st) at the beginning (CI), 2nd) at 30 min (CM) and the 3rd) at the end of the dialysis session (CP). In CI and CP the following parameters were measured: haemoglobin, proteins and albumin, urea, phosphorus, creatinine, uric acid, β2-microglobulin, myoglobin and retinol transport protein (RTP). Leukocytes, platelets, C3a and C5a were quantified in CI and CM. --- Laboratory determinations
- General biochemical data: haemoglobin, proteins, albumin, urea, phosphorus, reactive protein C (PCR), creatinine and uric acid, β2-microglobulin, myoglobin, and (RTP) were determined with the usual analyser of each hospital.
- Determinations of monocytes, complement, IL-6 and IL-1β were performed in the laboratory of the University of Alcalá:
- Activation of plasma complement using a sandwich ELISA: Determination of C3a and C5a activation was performed on platelet rich plasma samples using commercially available ELISA kits C3a Elabscience (Wuhan, P.R. China) and ELISA C5a RayBiotech (Norcross, Georgia).
- Determination of interleukin concentration in serum using a sandwich ELISA: IL-6 and IL-1β concentrations were measured in serum samples obtained from whole blood and stored at -80 ° C until use. Both kits used were supplied by Abcam (Cambridge, UK)
- Determination of monocyte subpopulations: The different subpopulations of circulating monocytes in peripheral blood were identified by flow cytometry (FACSCalibur™, Becton Dickinson, San Jose, CA, USA). First of all, the monocyte population was selected according to size (FSC/forward scatter) and granularity (SSC/side scatter) and then the different subpopulations were selected by double immunofluorescence according to staining with the anti-CD14 conjugated Tricolor (monoclonal antibodies TuK4) and anti-CD16 conjugated FITC (monoclonal antibodies 3G8). Both antibodies and their respective isotype controls were purchased from Life Technologies Invitrogen (California, USA). The analysis was performed with the Cyflogic program.
- Calculations The percentages of reduction (RR) were calculated with the formula: RR (%) = [(Cpre - Cpos) / Cpre] x 100, where Cpre and Cpos are the concentrations of the analysed substances pre- and post-dialysis. For protein bound substances and β2-microglobulin concentrations at the end of the session were corrected for haemoconcentration by a correction factor (FC) based on plasma protein concentration (PT): FC = PTpre / PTpos, where PTpre and PTpos are the total concentration of proteins pre-dialysis and post-dialysis. --- Statistical analysis All data was collected in a database (SPSS version 15). Each value was obtained with the average of the values obtained in the different sessions or analytical determinations. For the statistical analysis, descriptive tools were used, showing the average (standard deviation), median, quartiles or percentages as appropriate. For the comparison of two independent continuous variables, the Student t test for paired samples was used. For the comparison of more than two quantitative variables the ANOVA test was used. The p <0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (1 listed)
- Criteria:being over 18 years old, being treated with OLHDF for more than 4 weeks with 3 weekly sessions and sign an informed consent form.
Key exclusion criteria (1 listed)
- pregnancy and illness that would make the patient's death predictable in less than 4 weeks.
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 |
|---|---|---|
| Asymmetric cellulose triacetate (ATA™)Also: Solacea™Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer | Device | – |
Primary outcome
Performance of asymmetric cellulose triacetate (ATA™)
Time frame: One month
Describing in vivo depurative efficacy of asymmetric cellulose triacetate (ATA™) measuring Kt, infusion volumen and clearance of RR of different molecules
Biocompatibility of asymmetric cellulose triacetate (ATA™)
Time frame: One month
Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)
Clinical behaviour of ATA
Time frame: One month
Studuying alarm or clínical problemas related with dialyzer
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 10 Apr 2017.
- Results publication: PubMed 10917004Maduell F, Navarro V, Hernandez-Jaras J, Calvo C. [Comparison of dialyzers in on-line hemodiafiltration]. Nefrologia. 2000 May-Jun;20(3):269-76. Spanish.
- Results publication: PubMed 27951571Sunohara T, Masuda T. Fundamental Characteristics of the Newly Developed ATA Membrane Dialyzer. Contrib Nephrol. 2017;189:215-221. doi: 10.1159/000451044. Epub 2016 Dec 12.
- Results publication: PubMed 25036066Sanchez-Villanueva RJ, Gonzalez E, Quirce S, Diaz R, Alvarez L, Menendez D, Rodriguez-Gayo L, Bajo MA, Selgas R. Hypersensitivity reactions to synthetic haemodialysis membranes. Nefrologia. 2014;34(4):520-5. doi: 10.3265/Nefrologia.pre2014.May.12552. English, Spanish.
- Results publication: PubMed 27951569Mineshima M. Optimal Design of Dialyzers. Contrib Nephrol. 2017;189:204-209. doi: 10.1159/000450802. Epub 2016 Dec 12.
- Results publication: PubMed 21865788Sunohara T, Masuda T. Cellulose triacetate as a high-performance membrane. Contrib Nephrol. 2011;173:156-163. doi: 10.1159/000329055. Epub 2011 Aug 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetric cellulose triacetate (ATA™) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
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 1 inclusion and 1 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 10 Apr 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 Spain. 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?
Performance of asymmetric cellulose triacetate (ATA™) (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105817, which also lists 5 linked publications.
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 10 Apr 2017.