Effect of HCO1100 on Cardiovascular Function

Not Applicable

Terminated

• Conditions: Chronic Kidney Failure; Cardiovascular Disease
• Interventions: Device: HCO 1100

• Registration Number: NCT01363921
• Lead Sponsor: Vantive Health LLC

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.

Detailed Description

Cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. It is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. High porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. In this study, the high porous dialysis membrane HCO1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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)

Exclusion Criteria

• Diabetes mellitus as the disease underlined end stage renal failure
• Haemodynamic instability that precludes unsupported dialysis
• planned surgical interventions <= 4 months at time of inclusion
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialysis treatment with HCO1100	HCO 1100	-

Primary Outcome Measures

Name	Time	Method
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)	max 15 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Weekly assessment of albumin plasma levels (g/l)	max 15 weeks	Weekly evaluation of albumin plasma levels (g/l) during the study. Patients with albumin plasma levels below 35g/l will terminate study product (HCO1100 dialyzer) treatment phase and switch to study phase with control standard dialyzer treatment and will be further monitored for 6 weeks. Number of patients with decreased albumin levels below 35g/l , Number of patients with requirement for albumin substitution and absolute albumin drop (g/l) will be evaluated.

Trial Locations

Locations (1)

Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen; 🇩🇪 Aachen, NRW, Germany