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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 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/show/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.
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.
Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86.
Public notes

Contacts
Principal investigator
Name 0 0
Björn KI Meijers, MD
Address 0 0
Universitaire Ziekenhuizen 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
Other publications