NCT01306149

Brief Summary

The aims of this study are

  1. 1.To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients.
  2. 2.To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
  3. 3.To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

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

July 1, 2002

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

14.6 years

First QC Date

February 23, 2011

Last Update Submit

October 24, 2017

Conditions

Complication of Peritoneal Dialysis

Keywords

biochemical parametersmineral metabolismprotein-bound uremic retention solutesincident PD patients

Outcome Measures

Primary Outcomes (1)

  • natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins

    To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules, and protein bound URM in incident peritoneal dialysis (PD) patients.

    15 years

Secondary Outcomes (1)

  • determinants of generation rate of uremic retention solutes

    15 years on average

Eligibility Criteria

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

Incident peritoneal dialysis patients

You may qualify if:

  • written informed consent
  • age \> 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, urine and dialysate

Study Officials

  • Pieter Evenepoel, MD,PhD

    University Hospital, Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2011

First Posted

March 1, 2011

Study Start

July 1, 2002

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

BE(1)