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

Complication of Peritoneal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306149
• Other study ID #: FWO01-03-21
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: October 24, 2017
• Start date: July 2002
• Est. completion date: January 31, 2017

Study information

• Verified date: October 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Peritoneal Dialysis

Locations

Country	Name	City	State
Belgium	University Hospital	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins	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.	15 years
Secondary	determinants of generation rate of uremic retention solutes	To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.	15 years on average