Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 disea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00214721
Start Date
February 1 2005
End Date
July 1 2006
Last Update
March 3 2025
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6