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

Completed

• Conditions: Complication of Peritoneal Dialysis

• Registration Number: NCT01306149
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins	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

Name	Time	Method
determinants of generation rate of uremic retention solutes	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.

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Leuven, Vlaams-Brabant, Belgium