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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 28, 2016
Kidney Failure, Chronic
Renal Insufficiency, Chronic