Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis (NOCTX)

This study is currently recruiting participants.
Verified February 2014 by Dianet Dialysis Centers
Sponsor:
Information provided by (Responsible Party):
Dianet Dialysis Centers
ClinicalTrials.gov Identifier:
NCT00950573
First received: July 31, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

Objective:

  1. To assess whether nocturnal hemodialysis and renal transplantation are associated with less progression of coronary arterial calcification, compared with conventional hemodialysis and peritoneal dialysis;
  2. To identify the risk factors for coronary arterial calcification in dialysis and transplant patients, and to assess a possible interaction with treatment modality.

Condition
Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?

Resource links provided by NLM:


Further study details as provided by Dianet Dialysis Centers:

Primary Outcome Measures:
  • Change in coronary artery calcification score [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

1x 4,5 ml citrate plasma

1x 10 ml EDTA plasma


Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
hemodialysis
patients treated with hemodialysis
peritonealdialysis
patients treated with peritoneal dialysis
nocturnaldialysis
patients treated with frequent nocturnal hemodialysis
kidney transplantation
patients treated with renal transplantation

Detailed Description:

To assess whether nocturnal hemodialysis and renal transplantation are associated with less progression of coronary arterial calcification, compared with conventional hemodialysis and peritoneal dialysis; To identify the risk factors for coronary arterial calcification in dialysis and transplant patients, and to assess a possible interaction with treatment modality.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ESRD

Criteria

Inclusion Criteria:

  • ESRD
  • current age > 18 and < 75 yr
  • ability to understand the study procedures
  • willingness to provide written informed consent

Exclusion Criteria:

  • life expectancy < 3 months
  • claustrophobia
  • allergy to iodinated contrast
  • treatment incompliance, i.e. non-adherence to dialysis regimens and drug use
  • GFR < 30 ml/min (according to MDRD formula) in renal transplant patients
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950573

Contacts
Contact: Brigit van Jaarsveld, MD, PhD +31 20 4444444 b.jaarsveld@vumc.nl
Contact: Franka van Reekum, MD +31 88 7555555 f.vanreekum@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Franka E van Reekum, MD    +31 88 7555555    f.vanreekum@umcutrecht.nl   
Principal Investigator: Franka E van Reekum, MD         
Dianet Dialysis Centers Recruiting
Utrecht, Netherlands, 3524BN
Contact: M Kooistra, MD, PhD    +31 30 880 8888      
Sponsors and Collaborators
Dianet Dialysis Centers
Investigators
Principal Investigator: Brigit van Jaarsveld, dr VU University Medical Center
  More Information

No publications provided

Responsible Party: Dianet Dialysis Centers
ClinicalTrials.gov Identifier: NCT00950573     History of Changes
Other Study ID Numbers: NOCTX
Study First Received: July 31, 2009
Last Updated: February 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Dianet Dialysis Centers:
cardiovascular disease
endstage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014