Determination In-vivo KUF for Diacap Pro Hemodialyser

B. Braun

Status: Completed

Conditions: Kidney Insufficiency; Renal Insufficiency,Chronic; Kidney Disease, End-Stage; Kidney Failure,Chronic

Treatments: Device: Diacap Pro High-Flux

Study type: Interventional

Funder types: Industry

Identifiers

NCT02964429

BA-G-H-1602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Diacap Pro High-Flux

Experimental group

Description:

1.3/ 1.6/ 1.9 sqm

Treatment:

Device: Diacap Pro High-Flux