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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00930423
First received: June 29, 2009
Last updated: February 1, 2013
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]
  • white blood cell count [ Time Frame: before and after 15 minutes of hemodialysis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 25
Study Start Date: August 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00930423     History of Changes
Other Study ID Numbers: 2009/270
Study First Received: June 29, 2009
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Syndrome
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Urologic Diseases
Disease
Pathologic Processes
Uremia
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders

ClinicalTrials.gov processed this record on September 30, 2014