A Study to Evaluate the Efficacy and Safety of Extraneal Physiological pH Compared with Current Extraneal in Patients Receiving Continuous Ambulatory Peritoneal Dialysis (CAPD).

Baxter R&D Europe SCR0 sites120 target enrollmentAugust 26, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2005

End Date

May 29, 2006

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Baxter R&D Europe SCR

•1\. Patients who have given written informed consent after the nature of the study has been explained.
•2\. Patients who are at least 18 years of age.
•3\. Patients who have been treated with CAPD with Physioneal 40 or Dianeal PD4 and current Extraneal for at least 60 days before the baseline visit (week –2\).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•1\. Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit (week –4\). Peritonitis being defined as 2 out of 3 of the following criteria:
•a) Cloudy peritoneal effluent with peritoneal white blood cell (WBC) count \> 100 cells/mm3 due predominately to neutrophils (\>50%), (\= 1L dialysate after \= 2h dwell time).
•b) Signs and symptoms of peritoneal inflammation (e.g., abdominal pain).
•c) Demonstration of microorganism or yeast in the peritoneal effluent by culture or Gram’s stain.
•2\. 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 (week –4\).
•3\. Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
•4\. Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit (week –2\).
•5\. Patients who have severe malnutrition (serum albumin \< 25 g/l by bromocresol green method).
•6\. Patients who are participating in another study that requires Ethics Committee approval. Non\-interventional studies are permitted.
•7\. Patients who have received an investigational product within 30 days preceding the screening visit.