Determination In-vivo KUF for Diacap Pro Hemodialyser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2016-12-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Failure,Chronic Renal Insufficiency,Chronic Kidney Disease, End-Stage Kidney Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diacap Pro High-Flux

1.3/ 1.6/ 1.9 sqm

Group Type EXPERIMENTAL

Diacap Pro High-Flux

Intervention Type DEVICE

During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF.

Interventions

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Diacap Pro High-Flux

During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No