This trial is active, not recruiting.

Condition kidney failure
Treatments fx100 dialyzer, solacea 21h
Sponsor University College, London
Start date September 2015
End date June 2016
Trial size 10 participants
Trial identifier NCT02546037, REC: 08/H0724/11


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)
solacea 21h
comparison of dialyzers
single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)
fx100 dialyzer Fresenius FX 100
comparison of dialyzers

Primary Outcomes

convective volume exchanged
time frame: day 1

Secondary Outcomes

platelet and coagulation pathway activation
time frame: day 1
visual coagulation
time frame: day 1
small and middle sized solute clearances
time frame: day 1

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Patients not fulfilling inclusion criteria

Additional Information

Official title Pilot Study to Determine the Effect of Different Dialyzer Membranes on Clotting During Haemodiafiltration Treatments in Patients With Chronic Kidney Disease
Principal investigator andrew davenport
Description This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.