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Determination In-vivo KUF for Diacap Pro Hemodialyser

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ClinicalTrials.gov Identifier: NCT02964429
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Winicker Norimed GmbH
Information provided by (Responsible Party):
B.Braun Avitum AG

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.

Condition or disease Intervention/treatment Phase
Kidney Failure,Chronic Renal Insufficiency,Chronic Kidney Disease, End-Stage Kidney Insufficiency Device: Diacap Pro High-Flux Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : December 23, 2016
Actual Study Completion Date : December 23, 2016

Arm Intervention/treatment
Experimental: Diacap Pro High-Flux
1.3/ 1.6/ 1.9 sqm
Device: 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.




Primary Outcome Measures :
  1. Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF) [ Time Frame: For two of three dialysis sessions each week for a total study period of six weeks ]
    UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented.


Secondary Outcome Measures :
  1. Clearance data dialyzer [ml/min] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    For ß2M; Myoglobin; Retinol-Binding-Protein; alpha-1-Microglobulin; Albumin clearance data will be assessed by using serum samples pre- and post dialyzer at timepoints t=0 and t=240 min.

  2. Reduction rates dialyzer [%] [ Time Frame: For two of three dialysis sessions each week for a total study period of six weeks ]
    For urea; creatinine; phosphate; ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein; alpha-1 Microglobulin and Albumin reduction rates will be calculated by using serum-levels at timepoints t=0 and t=240 min.

  3. Total removal of proteins [mg/session] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    Spent dialysate will be collected during the entire dialysis treatment. Considering dialysate flow rate and ultrafiltration volume concentration of ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein;alpha-1 Microglobulin; Albumin; Total Protein will be used to calculate total removal by multiplying with the effective spent dialysate volume

  4. Complement-activation C3a and C5a [ng/ml] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    For complement activation C3a [ng/ml]; C5a [ng/ml] will be assessed at timepoints t=0, t=15; t=60; t=240 min.

  5. Complement-activation TAT III [µg/l] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    For complement activation TAT III [µg/l] will be assessed at timepoints t=0, t=15; t=60; t=240 min.

  6. Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    For inflammatory response Interleukin-1 [pg/ml]; Interleukin-6 [pg/ml]; TNF-alpha will be assessed at timepoints t=0; t=15; t=60; t=240 min

  7. Inflammatory response CRP [mg/l] [ Time Frame: For one of six dialysis sessions each two weeks for a total study period of six weeks ]
    For inflammatory response CRP[mg/l] will be assessed at timepoints t=0; t=15; t=60; t=240 min

  8. Incidence of Treatment-Emergent Adverse Events [ Time Frame: November 2016 up to 2 months ]
    Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964429


Locations
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Czech Republic
Interní oddělení Strahov VFN
Praha, Czech Republic, 169 00 Praha 6
Sponsors and Collaborators
B.Braun Avitum AG
Winicker Norimed GmbH
Investigators
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Principal Investigator: Vladimir Polakovic, Prim. MUDr. Interni oddeleni Strahov VFN

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Responsible Party: B.Braun Avitum AG
ClinicalTrials.gov Identifier: NCT02964429     History of Changes
Other Study ID Numbers: BA-G-H-1602
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases