NCT01093456

Brief Summary

Study on the daytime variation of uremic retention solutes and markers of bone-mineral metabolism in patients with end-stage kidney disease treated with peritoneal dialysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Typical duration 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

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 13, 2016

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

March 23, 2010

Last Update Submit

May 12, 2016

Conditions

Chronic Kidney Disease

Keywords

diurnal variationperitoneal dialysisuremic retention solutesphosphorousindoxyl sulfatep-cresol sulfate

Outcome Measures

Primary Outcomes (1)

  • To evaluate the diurnal variation of serum concentrations of phosphate and protein fermentation metabolites in healthy volunteers as compared to dialysis patients.

    4 months

Study Arms (2)

chronic kidney disease

ESKD patients treated with peritoneal dialysis

Healthy volunteers

healthy volunteers, aged 18 years and above

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Peritoneal dialysis patients Healthy volunteers

You may qualify if:

  • Age 18-55
  • Normal dietary habits

You may not qualify if:

  • Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pieter Evenepoel, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2016

Record last verified: 2013-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)