Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis

NCT00950573 | Completed

• 1 other identifier: NOCTX
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

Objective:

1. 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. 2.To identify the risk factors for coronary arterial calcification in dialysis and transplant patients, and to assess a possible interaction with treatment modality.

Conditions

Kidney Disease

Keywords

cardiovascular disease; endstage renal disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ESRD

You may qualify if:

• ESRD
• current age \> 18 and \< 75 yr
• ability to understand the study procedures
• willingness to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dianet Dialysis Centers: lead

Study Sites (2)

Dianet Dialysis Centers

Utrecht, 3524BN, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1x 4,5 ml citrate plasma 1x 10 ml EDTA plasma

MeSH Terms

Conditions

Kidney Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Brigit van Jaarsveld, MD, PHD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 3, 2009
• Study Start: January 1, 2010
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

NL (2)