Trial Review

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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
Date last updated
13/05/2016

Titles & IDs
Public title
Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis
Scientific title
A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis
Secondary ID [1] 0 0
NHD002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Start hemodialysis during 2007
* Age over 18 years
* Informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brabant
Country [2] 0 0
Belgium
State/province [2] 0 0
Limburg

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen KU Leuven
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis
Trial website
https://clinicaltrials.gov/study/NCT00417339
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.
Public notes

Contacts
Principal investigator
Name 0 0
Björn KI Meijers, MD
Address 0 0
Universitaire Ziekenhuizen KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00417339