NCT00417339

Brief Summary

Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

8 years

First QC Date

December 28, 2006

Last Update Submit

May 12, 2016

Conditions

End Stage Kidney Disease

Keywords

hemodialysisdialysis adequacyuremic retention solute

Study Arms (4)

hemodialysis, 4h, twice weekly

hemodialysis, four hours, twice weekly

Procedure: hemodialysis

hemodialysis, 8h, twice weekly

hemodialysis, eight hours, twice weekly

Procedure: hemodialysis

hemodialysis, 8h, every other day

hemodialysis, eight hours, every other day

Procedure: hemodialysis

hemodialysis, 8h, six days per week

hemodialysis, eight hours, six days per week

Procedure: hemodialysis

Interventions

hemodialysisPROCEDURE

individualised

hemodialysis, 4h, twice weeklyhemodialysis, 8h, every other dayhemodialysis, 8h, six days per weekhemodialysis, 8h, twice weekly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

maintenance dialysis patients

You may qualify if:

  • Start hemodialysis during 2007
  • Age over 18 years
  • Informed consent

You may not qualify if:

  • Non consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Universitaire Ziekenhuizen Leuven

Leuven, Brabant, 3000, Belgium

Location

Virga Jesseziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 16421516BACKGROUND

  • 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.

    PMID: 12148107BACKGROUND

  • 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.

    PMID: 15086951BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine, dialysate

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Björn KI Meijers, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Pieter Evenepoel, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR

  • Tom Dejagere, MD

    Virga Jesse Ziekenhuis

    PRINCIPAL INVESTIGATOR

  • Nigel Toussaint, MD

    Geelong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)AU(2)