A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
This study has been completed.
Information provided by:
Baxter Healthcare Corporation
First received: September 8, 2005
Last updated: November 28, 2007
Last verified: November 2007
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.
End Stage Renal Disease
Drug: Experimental Peritoneal Dialysis Solution
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00214721
|St. Paul's Hospital
|Vancouver, British Columbia, Canada, V6Z 1Y6 |
Baxter Healthcare Corporation
||Baxter Healthcare Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||November 28, 2007
||Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Denmark: Danish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 25, 2016
Kidney Failure, Chronic
Renal Insufficiency, Chronic