Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis

Kidney Disease Clinical Trial

— NOCTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950573
• Other study ID #: NOCTX
• Status: Completed
• Start date: January 2010
• Est. completion date: December 12, 2018

Study information

• Verified date: December 2018
• Source: Dianet Dialysis Centers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Locations

Country	Name	City	State
Netherlands	Dianet Dialysis Centers	Utrecht
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Dianet Dialysis Centers

Country where clinical trial is conducted

Netherlands, 

Outcome

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