Clinical trial NCT02964429: Determination In-vivo KUF for Diacap Pro Hemodialyser
Official title: Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure,Chronic
Renal Insufficiency,Chronic
Kidney Disease, End-Stage
Kidney Insufficiency
Lead sponsor: B.Braun Avitum AG
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2016-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.

Detailed description: The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.

Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained from patient or parents/ guardian.
2. Subject age \> 18
3. Effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 ml/min
4. On hemodialysis for a minimum of 3 months
5. Use of Cimino- or Gore-tex shunts
6. Routine dialysis-treatment for 240 min and 3 times per week
7. Documented dialysis adequacy parameter spKt/V \>=1.2 that has been stable for past 3 months
8. Plan to dialyze at participating hemodialysis center for at least 3-months duration.
9. Free from any currently known unusual clotting or access problems
10. Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
11. Anti HCV negative, documented within the past 90 days
12. Anti HIV negative, documented within the past 90 days Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL

Exclusion Criteria:

1. Patients who are unable to tolerate an effective blood flow of 350 ml/min
2. Patients using catheter for dialysis
3. Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period
4. Previous plan for extended absences from the participating hemodialysis centre
5. Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
6. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study

Primary outcomes:
measure: Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
timeFrame: For two of three dialysis sessions each week for a total study period of six weeks
Secondary outcomes:
measure: Clearance data dialyzer [ml/min]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Reduction rates dialyzer [%]
timeFrame: For two of three dialysis sessions each week for a total study period of six weeks
measure: Total removal of proteins [mg/session]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Complement-activation C3a and C5a [ng/ml]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Complement-activation TAT III [µg/l]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Inflammatory response CRP [mg/l]
timeFrame: For one of six dialysis sessions each two weeks for a total study period of six weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: November 2016 up to 2 months
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Interní oddělení Strahov VFN
Study officials:
affiliation: Interni oddeleni Strahov VFN
name: Vladimir Polakovic, Prim. MUDr.
role: PRINCIPAL_INVESTIGATOR
References: