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Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930423
First Posted: June 30, 2009
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the alternative pathway of the complement system. Triggering can cause an uncontrolled complement activation with endothelial damage and thrombotic micro-angiopathy, especially in the kidneys. This can result in endstage renal failure. Complement activation during hemodialysis has been described as a result of contact between blood and the dialysis membrane. Our hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger complement activation during hemodialysis than patients with another underlying kidney disease. This could be a reason to treat patients with endstage renal failure due to atypical hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.

Condition
Atypical Hemolytic Uraemic Syndrome.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • C3a-des-Arg measuring (as a marker of activation). [ Time Frame: at time 0, at 15 minutes, at 60 minutes and at 180 minutes ]
  • white blood cell count [ Time Frame: before and after 15 minutes of hemodialysis ]

Biospecimen Retention:   Samples With DNA
blood samples

Estimated Enrollment: 25
Study Start Date: August 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
cases
patients with endstage renal failure due to atypical uraemic syndrome treated with hemodialysis.
controls
patiënts with endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with endstage renal failure treated in het University Hospital of Ghent
Criteria

Inclusion Criteria:

  • cases: endstage renal failure due to atypical hemolytic uraemic syndrome treated with hemodialysis.
  • controls: endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930423


Contacts
Contact: Rogier Caluwé, MD rogier.caluwe@uzgent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Rogier Caluwé, MD       rogier.caluwe@uzgent.be   
Principal Investigator: Raymond Vanholder, MD, PhD         
Sub-Investigator: Rogier Caluwé, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00930423     History of Changes
Other Study ID Numbers: 2009/270
First Submitted: June 29, 2009
First Posted: June 30, 2009
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Syndrome
Kidney Diseases
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Disease
Pathologic Processes
Urologic Diseases
Uremia
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs