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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306149
First Posted: March 1, 2011
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
  Purpose

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
Complication of Peritoneal Dialysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Björn Meijers, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 96
Actual Study Start Date: July 2002
Study Completion Date: January 31, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Björn Meijers, Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01306149     History of Changes
Other Study ID Numbers: FWO01-03-21
First Submitted: February 23, 2011
First Posted: March 1, 2011
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