- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00950573
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:
- 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 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.
Sponsor
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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