Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 16, 2013
Last verified: December 2013

February 23, 2011
December 16, 2013
July 2002
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01306149 on ClinicalTrials.gov Archive Site
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.
determinants of generation rate of uremic retention solutes [ Time Frame: 15 years ] [ 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.
Not Provided
Not Provided
 
Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients
Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, serum, urine and dialysate

Non-Probability Sample

Incident peritoneal dialysis patients

Complication of Peritoneal Dialysis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pieter Evenepoel, MD,PhD 003216344580 pieter.evenepoel@uz.kuleuven.ac.be
Belgium
 
NCT01306149
FWO01-03-21
No
Björn Meijers, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Pieter Evenepoel, MD,PhD University Hospital, Leuven, Belgium
Universitaire Ziekenhuizen Leuven
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP