NCT02964429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2016

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

October 28, 2016

Last Update Submit

February 6, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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.

    For two of three dialysis sessions each week for a total study period of six weeks

Secondary Outcomes (8)

  • Clearance data dialyzer [ml/min]

    For one of six dialysis sessions each two weeks for a total study period of six weeks

  • Reduction rates dialyzer [%]

    For two of three dialysis sessions each week for a total study period of six weeks

  • Total removal of proteins [mg/session]

    For one of six dialysis sessions each two weeks for a total study period of six weeks

  • Complement-activation C3a and C5a [ng/ml]

    For one of six dialysis sessions each two weeks for a total study period of six weeks

  • Complement-activation TAT III [µg/l]

    For one of six dialysis sessions each two weeks for a total study period of six weeks

  • +3 more secondary outcomes

Study Arms (1)

Diacap Pro High-Flux

EXPERIMENTAL

1.3/ 1.6/ 1.9 sqm

Device: Diacap Pro High-Flux

Interventions

Diacap Pro High-FluxDEVICE

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.

Diacap Pro High-Flux

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interní oddělení Strahov VFN

Prague, 169 00 Praha 6, Czechia

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir Polakovic, Prim. MUDr.

    Interni oddeleni Strahov VFN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 16, 2016

Study Start

November 14, 2016

Primary Completion

December 23, 2016

Study Completion

December 23, 2016

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)