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Determination In-vivo KUF for Diacap Pro Hemodialyser | Clinical Trials | Clareo Health

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Determination In-vivo KUF for Diacap Pro Hemodialyser

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

NCT02964429•B.Braun Avitum AG

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

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

Locations (1)

Interní oddělení Strahov VFN

Prague, Czechia

Key Dates

Start Date

November 14, 2016

Primary Completion Date

December 23, 2016

Completion Date

December 23, 2016

Last Updated

February 7, 2017

Enrollment

ACTUAL participants

Conditions

Kidney Failure,ChronicRenal Insufficiency,ChronicKidney Disease, End-StageKidney Insufficiency

Interventions

Diacap Pro High-Flux

DEVICE

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

View study

RECRUITING

Rutgers University Study of the Genetics of Kidney Disease

NCT07217535

Kidney DiseaseKidney Disease, Chronic+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Determination In-vivo KUF for Diacap Pro Hemodialyser

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Rutgers University Study of the Genetics of Kidney Disease

Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

PATH-03 Paraguay Feasibility Study

Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)