NCT00766792

Brief Summary

Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

2.6 years

First QC Date

October 3, 2008

Last Update Submit

October 30, 2008

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

  • To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?

    30 weeks

Study Arms (2)

1

EXPERIMENTAL

Nocturnal dialysis

Procedure: Nocturnal dialysis

2

ACTIVE COMPARATOR

Standard dialysis

Procedure: Standard dialysis

Interventions

Nocturnal dialysisPROCEDURE

Switch to nocturnal dialysis (3 times 480 min/week)

1
Standard dialysisPROCEDURE

Standard dialysis (3 times 240-270 min/week)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Officials

  • Raymond Vanholder, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

December 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

BE(1)