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Completed

NCT Number: NCT02964429

Determination In-vivo KUF for Diacap Pro Hemodialyser

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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Key information

Conditions

Kidney Failure,Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease, End-Stage Kidney Diseases Kidney Failure, Chronic Kidney Insufficiency Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Insufficiency,Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interní oddělení Strahov VFN

Prague, 169 00 Praha 6, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diacap Pro High-Flux

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

B.Braun Avitum AG

Industry

Collaborators

  • Winicker Norimed GmbH

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2016
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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