Kidney Disease Clinical Trial
— NOCTXOfficial title:
Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?
NCT number | NCT00950573 |
Other study ID # | NOCTX |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | December 12, 2018 |
Verified date | December 2018 |
Source | Dianet Dialysis Centers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 184 |
Est. completion date | December 12, 2018 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Dianet Dialysis Centers | Utrecht | |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Dianet Dialysis Centers |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in coronary artery calcification score | 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 |
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