NCT03105817

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

March 27, 2017

Last Update Submit

April 3, 2017

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Asymmetric cellulose triacetateBiocompatibilityHemodiafiltration on-lineConvective volumeAdequacy

Outcome Measures

Primary Outcomes (3)

  • 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

    One month

  • Biocompatibility of asymmetric cellulose triacetate (ATA™)

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

    One month

  • Clinical behaviour of ATA

    Studuying alarm or clínical problemas related with dialyzer

    One month

Interventions

Asymmetric cellulose triacetate (ATA™)DEVICE

Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer

Also known as: Solacea™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy and illness that would make the patient's death predictable in less than 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marta Albalate Ramón

Madrid, Madrid, Spain

Location

Related Publications (5)

  • 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.

    PMID: 10917004RESULT

  • 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.

    PMID: 27951571RESULT

  • 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.

    PMID: 25036066RESULT

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

    PMID: 27951569RESULT

  • 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.

    PMID: 21865788RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 10, 2017

Study Start

February 1, 2016

Primary Completion

July 10, 2016

Study Completion

August 14, 2016

Last Updated

April 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)