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

December 17, 2018 updated by: Dianet Dialysis Centers

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Utrecht, Netherlands, 3524BN
        • Dianet Dialysis Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ESRD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brigit van Jaarsveld, MD, PHD, Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

July 31, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOCTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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