Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiovascular Disease Chronic Kidney Failure

Keywords

CKD5dialysishigh porous membranesmicro-inflammation

Outcome Measures

Primary Outcomes (1)

Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
Changes of CHRS (ms/mmHg) and FMD (%) between pre- and post- treatment phase with study product HCO1100 dialyzer and at 6 weeks follow up after termination of HCO1100 dialyzer treatment phase will be assessed.
max 15 weeks

Secondary Outcomes (1)

Weekly assessment of albumin plasma levels (g/l)
max 15 weeks

Study Arms (1)

Dialysis treatment with HCO1100

EXPERIMENTAL

Device: HCO 1100

Interventions

HCO 1100Device

Dialysis treatment with HCO1100

Also known as: High cut-off membrane

Dialysis treatment with HCO1100

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
Dialysis dependent chronic renal failure (CKD 5) in a stable condition

Sponsors & Collaborators

Gambro Dialysatoren GmbH
Industrycollaborator
Baxter Healthcare Corporation
Industrycollaborator
Vantive Health LLC

Study Sites (1)

Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

MeSH Terms

Conditions

Cardiovascular DiseasesKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Juergen Floege, MD
Med.Klinik II, Universitätsklinikum Aachen
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 2, 2011

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Effect of HCO1100 on Cardiovascular Function

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Dialysis treatment with HCO1100

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Dialysis treatment with HCO1100

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations