NCT02546037

Brief Summary

Primary Objective: The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

August 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

August 11, 2015

Last Update Submit

October 22, 2018

Conditions

Kidney Failure

Keywords

coagulationhaemodialysis

Outcome Measures

Primary Outcomes (1)

  • convective volume exchanged

    volume of convective exchange achieved during the HDF session

    day 1

Secondary Outcomes (3)

  • platelet and coagulation pathway activation

    day 1

  • visual coagulation

    day 1

  • small and middle sized solute clearances

    day 1

Study Arms (2)

SOLACEA 21H

single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)

Device: SOLACEA 21H

FX100

single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)

Device: FX100 dialyzer

Interventions

FX100 dialyzerDEVICE

comparison of dialyzers

Also known as: Fresenius FX 100
FX100
SOLACEA 21HDEVICE

comparison of dialyzers

SOLACEA 21H

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney disease

You may qualify if:

  • Patients age 18 years and older up to 80 years
  • Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
  • Able to provide written informed consent obtained

You may not qualify if:

  • Patients scheduled for a kidney transplant
  • Patients taking concomitant systemic anticoagulants
  • Patients with known prothrombotic or bleeding disorders
  • Patients with abnormal platelet counts
  • Patients unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal InsufficiencyThrombosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • andrew davenport

    UCL centre for nephrology, Royal Free Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 10, 2015

Study Start

September 30, 2016

Primary Completion

May 30, 2017

Study Completion

July 30, 2017

Last Updated

October 23, 2018

Record last verified: 2018-10