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

NCT ID: NCT00214721

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-07-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Experimental Peritoneal Dialysis Solution

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

PRO-RENAL-REG-062

Identifier Type: -

Identifier Source: org_study_id