A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Vantive Health LLC

Status and phase

Completed

Phase 3

Conditions

End Stage Renal Disease

Treatments

Drug: Experimental Peritoneal Dialysis Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00214721

PRO-RENAL-REG-062

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.