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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Spain1 site
  • Marta Albalate Ramón

    Madrid, Madrid

Other trials in Spain

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:
  1. 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
  1. Analytical determinations
  2. 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.

  1. 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

  2. Biocompatibility of asymmetric cellulose triacetate (ATA™)

    Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)

    Measured: One month

  3. 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.

  1. First posted10 Apr 2017
  2. Study start1 Feb 2016
  3. Primary completion10 Jul 2016
  4. Study completion14 Aug 2016

Resources

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)
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 10917004
  • Sunohara 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 27951571
  • Sanchez-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 25036066
  • Mineshima M. Optimal Design of Dialyzers. Contrib Nephrol. 2017;189:204-209. doi: 10.1159/000450802. Epub 2016 Dec 12.

    PubMed 27951569
  • Sunohara 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

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.

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