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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Experimental Peritoneal Dialysis Solution
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Paul's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
November 28, 2007
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00214721
Brief Title
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
Official Title
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

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 disease (ESRD) in peritoneal dialysis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Experimental Peritoneal Dialysis Solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene Stubbs
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

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

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