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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00417105

Registration number

NCT00417105

Ethics application status

Date submitted

28/12/2006

Date registered

29/12/2006

Date last updated

5/03/2009

Titles & IDs

Public title

Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

Scientific title

A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis

Secondary ID [1]

NHD001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

End Stage Renal Disease

Condition category

Condition code

Renal and Urogenital

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
Treatment: Surgery - hemodialysis
Treatment: Surgery - hemodialysis
Treatment: Surgery - hemodialysis

1 - hemodialysis twice weekly 4 hours

2 - nocturnal dialysis twice weekly 8 hours

3 - nocturnal hemodialysis, 8 hours every other night

4 - nocturnal hemodialysis, 8 hours, six times per week

Treatment: Surgery: hemodialysis
group 1: twice weekly, four hours

Treatment: Surgery: hemodialysis
group 2: twice weekly, eight hours

Treatment: Surgery: hemodialysis
group 3: every other day, eight hours

Treatment: Surgery: hemodialysis
group 4: six days a week, eight hours

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

removal of protein-bound retention solutes

Timepoint [1]

1 dialysis session

Eligibility

Key inclusion criteria

* Age > 18 years
* Maintenance hemodialysis (> 3 months duration)
* Informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* No 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

1/12/2008

Sample size

Target

Accrual to date

Final

120

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton

Recruitment hospital [2]

Geelong Hospital - Geelong

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3220 - Geelong

Recruitment outside Australia

Country [1]

Belgium

State/province [1]

Limburg

Country [2]

Belgium

State/province [2]

Vlaams-Brabant

Funding & Sponsors

Primary sponsor type

Other

Name

Universitaire Ziekenhuizen KU Leuven

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.

In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.

Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. ß2-microglobulin).

It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.

The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.

Trial website

https://clinicaltrials.gov/study/NCT00417105

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

Björn KI Meijers, MD

Address

Universitaire Ziekenhuizen KU Leuven

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

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/NCT00417105

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00417105