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Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT01306149
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven

Brief Summary:

The aims of this study are

  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. To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
  3. To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.

Condition or disease
Complication of Peritoneal Dialysis

Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study
Actual Study Start Date : July 2002
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals




Primary Outcome Measures :
  1. natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins [ Time Frame: 15 years ]
    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.


Secondary Outcome Measures :
  1. determinants of generation rate of uremic retention solutes [ Time Frame: 15 years on average ]
    To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.


Biospecimen Retention:   Samples Without DNA
whole blood, serum, urine and dialysate


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident peritoneal dialysis patients
Criteria

Inclusion Criteria:

  • Incident PD patients, defined as patients who started on PD as first renal replacement therapy less than 8 weeks before inclusion
  • written informed consent
  • age > 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306149


Locations
Belgium
University Hospital
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Pieter Evenepoel, MD,PhD University Hospital, Leuven, Belgium

Responsible Party: Björn Meijers, Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01306149     History of Changes
Other Study ID Numbers: FWO01-03-21
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Björn Meijers, Universitaire Ziekenhuizen Leuven:
biochemical parameters
mineral metabolism
protein-bound uremic retention solutes
incident PD patients