A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00214721
First received: September 8, 2005
Last updated: November 28, 2007
Last verified: November 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Renal Disease |
Drug: Experimental Peritoneal Dialysis Solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214721
Locations
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
| Study Director: | Charlene Stubbs | Baxter Healthcare Corporation |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00214721 History of Changes |
| Other Study ID Numbers: | PRO-RENAL-REG-062 |
| Study First Received: | September 8, 2005 |
| Last Updated: | November 28, 2007 |
| Health Authority: | 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:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013