Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014