NCT00752583

Brief Summary

Study in order to quantify toxin removal during dialysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 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

First Submitted

Initial submission to the registry

September 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2008

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

7.1 years

First QC Date

September 12, 2008

Last Update Submit

December 14, 2022

Conditions

Hemodialysis

Keywords

Chronic renal insufficiency (patients under dialysis)

Outcome Measures

Primary Outcomes (1)

  • Registration of toxin removal efficiency

    After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months

Study Arms (2)

1

EXPERIMENTAL

Peritoneal dialysis

Procedure: Peritoneal dialysis

2

ACTIVE COMPARATOR

Haemodialysis

Procedure: Haemodialysis

Interventions

Peritoneal dialysisPROCEDURE

Blood, urine and dialysate sampling

1
HaemodialysisPROCEDURE

Blood, urine and dialysate sampling

2

Eligibility Criteria

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

You may qualify if:

  • Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
  • Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
  • Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Peritoneal DialysisDialysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal DialysisRenal Replacement TherapyTherapeuticsSorption DetoxificationChemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Raymond Vanholder, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 15, 2008

Study Start

November 7, 2008

Primary Completion

November 30, 2015

Study Completion

December 31, 2015

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

BE(1)