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OpenTrials
Completed

NCT Number: NCT00950573

Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis

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.

Completed

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Key information

Conditions

Kidney Disease Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dianet Dialysis Centers, Utrecht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in coronary artery calcification score

    Time frame: 3 yrs

    The coronary artery calcification score is measured in Agatston units or cubic millimeters and ranges from zero to theoretically infite. This coronary artery calcicifcation score is a total score for all coronary arteries. A higher score, and thus a higher increase in coronary artery calcification score, therefore represents a worse outcome.

Sponsors and collaborators

Lead sponsor

Dianet Dialysis Centers

Other

Registry information

Official study title

Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?

Acronym: NOCTX

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2009
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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