NCT00735059

Brief Summary

A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high \[10\]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 13, 2008

Last Update Submit

August 20, 2009

Conditions

Chronic Kidney Disease

Keywords

dialysis membranePolynephronElisio HPolyethersulfoneDiapesPES-DSonline post-dilution hemodiafiltrationhemodialysisprotein-bound toxinsbeta-2-microglobulinhemodialysis patients

Outcome Measures

Primary Outcomes (3)

  • protein-bound toxin removal

    pre and post dialysis treatment

  • low-molecular weight protein removal

    pre and post dialysis treatment

  • small solute removal

    pre and post dialysis treatment

Study Arms (2)

1

EXPERIMENTAL

treatment with dialyzer ELISIO 170H

Device: treatment with the dialyzer ELISIO 170H

2

ACTIVE COMPARATOR

treatment with dialyzer PES-170DS

Device: treatment with the dialyzer PES-170DS

Interventions

treatment with the dialyzer ELISIO 170HDEVICE

one week of three consecutive dialysis treatments, \> 3 hours

1
treatment with the dialyzer PES-170DSDEVICE

one week of three consecutive dialysis treatments, \> 3 hours

2

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
  • Hematocrit \>30 %
  • Routine anticoagulation and erythropoietin regimen
  • No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
  • No ongoing infection
  • Signed informed consent form

You may not qualify if:

  • Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
  • Unstable clinical condition (e.g. cardiac or vascular instability)
  • Life expectancy less than 12 months
  • Known coagulation problems
  • Patients participating in another study interfering with the planned study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Ghent, B-9000, Belgium

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raymond Vanholder, Prof. Dr.

    University Hospital Ghent, Nephrology Section

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

BE(1)