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

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.
ClinicalTrials.gov Identifier: NCT00950573
Recruitment Status : Active, not recruiting
First Posted : August 3, 2009
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dianet Dialysis Centers

Brief Summary:

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 or disease
Kidney Disease

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.

Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?
Study Start Date : January 2010
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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

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): 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

Responsible Party: Dianet Dialysis Centers
ClinicalTrials.gov Identifier: NCT00950573     History of Changes
Other Study ID Numbers: NOCTX
First Posted: August 3, 2009    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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