Overview

A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
Objective: The purpose of this study is to demonstrate: -the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baxter Healthcare Corporation
Treatments:
Dialysis Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Patients who have given written informed consent after the nature of the study has
been explained.

- Patients who are at least 18 years of age.

- Patients who have been treated with CAPD using specific solutions for at least 60 days
before the baseline visit.

Exclusion Criteria:

- Patients who have received antibiotics for the treatment of an episode of peritonitis
within 30 days before the screening visit. - Patients who have had acute or chronic
exit-site or tunnel infection in the past 14 days, counted from the last day of
infection to the screening visit.

- Patients who have other serious diseases, such as active, or if previously treated,
residual malignancy or systemic infection.

- Patients who have had a major illness or injury requiring hospitalisation within 30
days before the baseline visit.

- Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green
method).

- Patients who are participating in another study that requires Ethics Committee
approval. Non-interventional studies are permitted.

- Patients who have received an investigational product within 30 days preceding the
screening visit.

- Patients who are pregnant or lactating. (NB: Female patients of childbearing potential
must have a negative urine or serum pregnancy test at the time of the screening and
will be required to use a medically acceptable means of contraception during their
participation in this study).

- Patients who have a significant psychiatric disorder or mental disability that could
interfere with his/her ability to provide informed consent and/or comply with protocol
procedures.