A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

The purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis (PD) patients.

Study Overview

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

• Study Type: Interventional
• Enrollment: 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 86
    • Huddinge Sjukhus, Njurmed kliniken K 56

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 PD using specific solutions for at least 30 days before the screening visit.
• Patients who experience pain on infusion based on medical judgement.

Exclusion Criteria:

• Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to 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 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: Crossover Assignment
• Masking: Double

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 14, 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 24, 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-064