Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00417339
Registration number
NCT00417339
Ethics application status
Date submitted
28/12/2006
Date registered
1/01/2007
Titles & IDs
Public title
Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis
Query!
Scientific title
A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis
Query!
Secondary ID [1]
0
0
NHD002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Surgery - hemodialysis
hemodialysis, 4h, twice weekly - hemodialysis, four hours, twice weekly
hemodialysis, 8h, twice weekly - hemodialysis, eight hours, twice weekly
hemodialysis, 8h, every other day - hemodialysis, eight hours, every other day
hemodialysis, 8h, six days per week - hemodialysis, eight hours, six days per week
Treatment: Surgery: hemodialysis
individualised
Query!
Intervention code [1]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Eligibility
Key inclusion criteria
* Start hemodialysis during 2007
* Age over 18 years
* Informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Non consent
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
38
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [2]
0
0
Geelong Hospital - Geelong
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
3220 - Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Brabant
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Limburg
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Universitaire Ziekenhuizen KU Leuven
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis
Query!
Trial website
https://clinicaltrials.gov/study/NCT00417339
Query!
Trial related presentations / publications
Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115. Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518. Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Björn KI Meijers, MD
Query!
Address
0
0
Universitaire Ziekenhuizen KU Leuven
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00417339