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Determination In-vivo KUF for Diacap Pro Hemodialyser

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Diacap Pro High-Flux
Sponsored by
B.Braun Avitum AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Failure,Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Interní oddělení Strahov VFN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diacap Pro High-Flux

Arm Description

1.3/ 1.6/ 1.9 sqm

Outcomes

Primary Outcome Measures

Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
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

Clearance data dialyzer [ml/min]
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.
Reduction rates dialyzer [%]
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.
Total removal of proteins [mg/session]
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
Complement-activation C3a and C5a [ng/ml]
For complement activation C3a [ng/ml]; C5a [ng/ml] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Complement-activation TAT III [µg/l]
For complement activation TAT III [µg/l] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
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
Inflammatory response CRP [mg/l]
For inflammatory response CRP[mg/l] will be assessed at timepoints t=0; t=15; t=60; t=240 min
Incidence of Treatment-Emergent Adverse Events
Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading.

Full Information

First Posted
October 28, 2016
Last Updated
February 6, 2017
Sponsor
B.Braun Avitum AG
Collaborators
Winicker Norimed GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02964429
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
December 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B.Braun Avitum AG
Collaborators
Winicker Norimed GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure,Chronic, Renal Insufficiency,Chronic, Kidney Disease, End-Stage, Kidney Insufficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diacap Pro High-Flux
Arm Type
Experimental
Arm Description
1.3/ 1.6/ 1.9 sqm
Intervention Type
Device
Intervention Name(s)
Diacap Pro High-Flux
Intervention Description
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 Measure Information:
Title
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
Description
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.
Time Frame
For two of three dialysis sessions each week for a total study period of six weeks
Secondary Outcome Measure Information:
Title
Clearance data dialyzer [ml/min]
Description
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.
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Reduction rates dialyzer [%]
Description
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.
Time Frame
For two of three dialysis sessions each week for a total study period of six weeks
Title
Total removal of proteins [mg/session]
Description
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
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Complement-activation C3a and C5a [ng/ml]
Description
For complement activation C3a [ng/ml]; C5a [ng/ml] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Complement-activation TAT III [µg/l]
Description
For complement activation TAT III [µg/l] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
Description
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
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Inflammatory response CRP [mg/l]
Description
For inflammatory response CRP[mg/l] will be assessed at timepoints t=0; t=15; t=60; t=240 min
Time Frame
For one of six dialysis sessions each two weeks for a total study period of six weeks
Title
Incidence of Treatment-Emergent Adverse Events
Description
Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading.
Time Frame
November 2016 up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained from patient or parents/ guardian. Subject age > 18 Effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 ml/min On hemodialysis for a minimum of 3 months Use of Cimino- or Gore-tex shunts Routine dialysis-treatment for 240 min and 3 times per week Documented dialysis adequacy parameter spKt/V >=1.2 that has been stable for past 3 months Plan to dialyze at participating hemodialysis center for at least 3-months duration. Free from any currently known unusual clotting or access problems Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive. Anti HCV negative, documented within the past 90 days 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: Patients who are unable to tolerate an effective blood flow of 350 ml/min Patients using catheter for dialysis Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period Previous plan for extended absences from the participating hemodialysis centre Expected to be transplanted (living related donor) within the maximum of 3 months for the study period 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Polakovic, Prim. MUDr.
Organizational Affiliation
Interni oddeleni Strahov VFN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interní oddělení Strahov VFN
City
Praha
ZIP/Postal Code
169 00 Praha 6
Country
Czech Republic

12. IPD Sharing Statement

Plan to Share IPD
No

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Determination In-vivo KUF for Diacap Pro Hemodialyser

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