Kidney DiseaseNOCTXNCT00950573
Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis
An observational study of Kidney Disease, run by Dianet Dialysis Centers at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Disease
- How many people
- 184 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2010to 12 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ESRD
Who may be able to join
- ESRD
- current age > 18 and < 75 yr
- ability to understand the study procedures
- willingness to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Dianet Dialysis Centers
Utrecht, 3524BN
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Disease
- Keywords
- cardiovascular disease, endstage renal disease
- Medical subject headings
- Kidney Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJan 2010
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dianet Dialysis Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigit van Jaarsveld, MD, PHD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950573
- Sponsor's protocol ID
- NOCTX
- Acronym
- NOCTX
- Status last verified
- Dec 2018
- First submitted
- 31 Jul 2009
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Progression of Arteriosclerosis in ESRD Patients Inhibited by Nocturnal Hemodialysis or Renal Transplantation?
- ClinicalTrials.gov ID
- NCT00950573
- Acronym / sponsor ID
- NOCTX / NOCTX
- Conditions
- Kidney Disease
- Keywords
- cardiovascular disease, endstage renal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Dianet Dialysis CentersUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ESRD
Key inclusion criteria (4 listed)
- ESRD
- current age > 18 and < 75 yr
- ability to understand the study procedures
- willingness to provide written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigit van Jaarsveld, MD, PHD principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by Dianet Dialysis Centers at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary artery calcification score (time frame: 3 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.