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OpenTrials
Completed

NCT Number: NCT01306149

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

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.

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Key information

Conditions

Complication of Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study

Important dates

Study start
2002
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2011
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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