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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dianet Dialysis Centers
ClinicalTrials.gov Identifier:
NCT00950573
First received: July 31, 2009
Last updated: February 7, 2017
Last verified: February 2017
July 31, 2009
February 7, 2017
January 2010
March 2019   (Final data collection date for primary outcome measure)
Change in coronary artery calcification score [ Time Frame: 3 yrs ]
Same as current
Complete list of historical versions of study NCT00950573 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis
Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?

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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

1x 4,5 ml citrate plasma

1x 10 ml EDTA plasma

Non-Probability Sample
Patients with ESRD
Kidney Disease
Not Provided
  • hemodialysis
    patients treated with conventional hemodialysis
  • peritoneal dialysis
    patients treated with peritoneal dialysis
  • nocturnal hemodialysis
    patients treated with frequent nocturnal hemodialysis
  • kidney transplantation
    patients treated with renal transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
184
May 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00950573
NOCTX
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Dianet Dialysis Centers
Dianet Dialysis Centers
Not Provided
Principal Investigator: Brigit van Jaarsveld, MD, PHD VU University Medical Center
Dianet Dialysis Centers
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP