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

This study is currently recruiting participants.

Verified April 2013 by Dianet Dialysis Centers

Sponsor:

Information provided by (Responsible Party):

Dianet Dialysis Centers

ClinicalTrials.gov Identifier:

NCT00950573

First received: July 31, 2009

Last updated: April 17, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition
Cardiovascular Disease in Patients With Endstage Renal Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure Kidney Transplantation

U.S. FDA Resources

Further study details as provided by Dianet Dialysis Centers:

Primary Outcome Measures:

Change in coronary artery calcification score [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 patients treated with hemodialysis
2 patients treated with peritoneal dialysis
3 patients treated with frequent nocturnal hemodialysis
4 patients treated with renal transplantation

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with ESRD

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950573

Contacts

Contact: Brigit van Jaarsveld, MD, PhD	+31 20 4444444	b.jaarsveld@vumc.nl
Contact: Franka van Reekum, MD	+31 88 7555555	f.vanreekum@umcutrecht.nl

Locations

Netherlands
University Medical Center Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Franka E van Reekum, MD +31 88 7555555 f.vanreekum@umcutrecht.nl
Principal Investigator: Franka E van Reekum, MD
Dianet Dialysis Centers	Recruiting
Utrecht, Netherlands, 3524BN
Contact: M Kooistra, MD, PhD +31 30 880 8888

Sponsors and Collaborators

Dianet Dialysis Centers

More Information

No publications provided

Responsible Party:	Dianet Dialysis Centers
ClinicalTrials.gov Identifier:	NCT00950573 History of Changes
Other Study ID Numbers:	NOCTX
Study First Received:	July 31, 2009
Last Updated:	April 17, 2013
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic

Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013

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