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

This study is currently recruiting participants.
Verified September 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01306149
First received: February 23, 2011
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  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:

MedlinePlus related topics: Dialysis Minerals
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: July 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306149

Contacts
Contact: Pieter Evenepoel, MD,PhD 003216344580 pieter.evenepoel@uz.kuleuven.ac.be

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

No publications provided

Responsible Party: Björn Meijers, Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01306149     History of Changes
Other Study ID Numbers: FWO01-03-21
Study First Received: February 23, 2011
Last Updated: September 28, 2011
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013