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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00214721
First received: September 8, 2005
Last updated: November 28, 2007
Last verified: November 2007
  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:

Estimated Enrollment: 120
Study Start Date: February 2005
Estimated Study Completion Date: July 2006
  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 April 16, 2014