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OpenTrials
Completed

NCT Number: NCT00214721

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.

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Peritoneal Dialysis Solution

Drug

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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