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CompletedNCT01093456Updated May 13, 2016

Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

An observational study in Chronic Kidney Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
18
Ages
18 Years to 55 Years
Sex
All
01

Study 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

Read the detailed description

Many epidemiological studies have pointed to the association between serum parameters of phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl sulphate [PCS], indoxyl sulphate [IS]) on the one hand and increased risk of all-cause and cardiovascular death on the other hand.

Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of serum phosphate and fermentation metabolites will be more pronounced in dialysis patients, especially in those with negligible residual kidney function.

Clinical studies assessing this issue are scarce to non-existing.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • diurnal variation
  • peritoneal dialysis
  • uremic retention solutes
  • phosphorous
  • indoxyl sulfate
  • p-cresol sulfate
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 18 is below the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Peritoneal dialysis patients Healthy volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-55
  • Normal dietary habits

Exclusion criteria

Exclusion Criteria:

  • Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
18 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • chronic kidney disease

    ESKD patients treated with peritoneal dialysis

  • Healthy volunteers

    healthy volunteers, aged 18 years and above

06

What researchers measure

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.

    Time frame: 4 months

07

Study locations

1 site
  • University Hospital
    Leuven, Vlaams-Brabant 3000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2010
First posted
Mar 25, 2010
Start
Feb 2010
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
May 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01093456
Responsible party
Sponsor
First posted
Mar 25, 2010
Start date
Feb 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
May 13, 2016

Study contacts

Pieter Evenepoel, MD, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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