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

NCT ID: NCT00214695

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-07-31

Brief Summary

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Experimental Peritoneal Dialysis Solution

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huddinge Sjukhus, Njurmed kliniken K 56

Huddinge, , Sweden

Countries

Sweden

Other Identifiers

PRO-RENAL-REG-064

Identifier Type: -

Identifier Source: org_study_id