Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:

Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578421
• Other study ID #: HD-FX-01-CH
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: August 6, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hemodialysis patients 18 years and older

• treated by post dilution on-line Hemodiafiltration (HDF) for at least one month

• who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks

• who are on a stable anticoagulation and anemia management

• whose hemoglobin is between 10.5 and 13.0 g/dl

• who are clinically stable based on judgment of nephrologist

• who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday,

• who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min)

• who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent

Exclusion Criteria: Patients

• with active Hepatitis B, Hepatitis C or HIV infection

• who are severely malnourished as judged by the principal investigator

• who are known or suspected to have allergy to the trial products or related products

• with a central venous catheter based vascular access

• who are abusing non-legal drugs or alcohol

• who have currently active malignant disease

• who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding

• who participate simultaneously in another clinical investigation

• who have participated in othe clinical investigations during the last month

• who are uncooperative

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

Device:
• 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)
4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements

Locations

Country	Name	City	State
Switzerland	Nephrology Division, Kantonsspital Aarau	Aarau

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Aarau	Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance and removal rate of phosphate, beta2 microglobulin and leptin	during a 4 hour online hemodiafiltration session	4 hour	No

External Links

•   Website of the Kantonsspital Aarau Nephrology Division