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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214721
• Other study ID #: PRO-RENAL-REG-062
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: November 28, 2007
• Start date: February 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2007
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaDenmark: Danish Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Experimental Peritoneal Dialysis Solution

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Canada,