NCT02240004

Brief Summary

The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

September 10, 2014

Last Update Submit

March 27, 2015

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

  • Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)

    12 weeks

Interventions

SUPRA HFRDEVICE

usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing dialysis three times week

You may qualify if:

  • Stable patients on hemodialysis for al least 3 month
  • older than 18 year old
  • dialyzed at least for two months with a high-flux membrane permeability
  • arteriovenous fistula with high blood flow (\> 350 ml / min)

You may not qualify if:

  • active neoplasia
  • positive viral markers (HBsAg, anti-HCV and HIV),
  • clinical signs of active infection and/or inflammation,
  • albumin \< 3.5 g/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HU Reina Sofia

Córdoba, Spain

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 15, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

ES(1)