Randomised controlled study of physiological” peritoneal dialysis solutions. - Physiological PD

Phase 1

• Conditions: End stage renal failure

• Registration Number: EUCTR2005-004360-23-GB
• Lead Sponsor: Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-11
• Study Completion: 2008-09-17
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

All incident patients selected to use a PD system that has physiological and standard solutions available.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients unable to provide informed consent
-Patients where the use of a certain solution is indicated or contra-indicated for medical reasons (e.g. known allergy).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the outcome of peritoneal dialysis when standard or biocompatible solutions are used. Primary end-point is: peritonitis rate. ;Secondary Objective: Secondary Endpoints:<br>·Patients using physiological solutions will have better preservation of residual kidney function.<br>·Patients using physiological solutions will have smaller changes in peritoneal membrane function assessed by PET than control<br>·Patients using physiological solutions will have reduced composite end-point of mortality and PD failure defined by transfer to HD<br>·Patients using physiological solutions will have better quality of life assessed by SF-36<br>;Primary end point(s): Primary aim is to compare peritonitis. However, some patients may have more than 1 episode