Effect of HCO1100 on Cardiovascular Function

NCT01363921 | Terminated

• 1 other identifier: HicoCARD 1481
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.

Conditions

Cardiovascular Disease; Chronic Kidney Failure

Keywords

CKD5; dialysis; high porous membranes; micro-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 1100 DEVICE

Dialysis treatment with HCO1100

Also known as: High cut-off membrane

Dialysis treatment with HCO1100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Dialysis dependent chronic renal failure (CKD 5) in a stable condition
• Serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value)

You may not qualify if:

• Diabetes mellitus as the disease underlined end stage renal failure
• Haemodynamic instability that precludes unsupported dialysis
• known allergy against dialysis membranes
• Significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; LV-EF \< 30%, clinically significant pericardial disease; cardiac amyloidosis)
• pulmonary disease with chronic hypoxia
• Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment
• Clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/L))
• Prior fistula surgery on both arms or other operations or paralysis on both arms
• Known HIV, HCV infection
• Alcoholism
• Active uncontrolled infection
• Pregnancy or lactation
• Inability to give informed consent to participate in the study

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Dialysatoren GmbH: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

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

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Juergen Floege, MD

  Med.Klinik II, Universitätsklinikum Aachen

  PRINCIPAL INVESTIGATOR

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 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (1)