High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

— HCO1100  

Official title:

Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974779
• Other study ID #: KIM2H-2009-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2009
• Last updated: January 13, 2012
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.

Description:

Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• regular hemodialysis for at least 3 months

• treatment thrice weekly

• high-flux hemodialyzer for at least 4 weeks

• age > 18 years and < 80 years

• at least one CRP value > 5mg/L within 8 weeks before inclusion

• able to understand and consent the study

• written informed consent

Exclusion Criteria:

• no consent

• clinically apparent acute infection

• CRP > 50 mg/L

• serum albumin < 3,5 mg/L

• central venous line as dialysis access

• immunosuppressive medication

• pregnancy or lactation

• inclusion into any other interventional trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• HCO1100 dialyzer
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
• regular dialysis polyamide
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers

Locations

Country	Name	City	State
Germany	Department of Internal Medicine II, Martin-Luther-University Medical School	Halle (Saale)	Sachsen-Anhalt

Sponsors (3)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Gambro Dialysatoren GmbH, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes		2 weeks	No
Secondary	Serum albumin losses		2 weeks	Yes