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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
  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 ]

Biospecimen Retention:   Samples Without DNA

1x 4,5 ml citrate plasma

1x 10 ml EDTA plasma


Enrollment: 184
Study Start Date: January 2010
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00950573

Locations
Netherlands
Dianet Dialysis Centers
Utrecht, Netherlands, 3524BN
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Dianet Dialysis Centers
Investigators
Principal Investigator: Brigit van Jaarsveld, MD, PHD VU University Medical Center
  More Information

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 7, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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 25, 2017