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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Experimental Peritoneal Dialysis Solution

• Study Type: Interventional
• Enrollment: 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Study Completion: July 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimated): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: PRO-RENAL-REG-062