Clinical Trial: Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Controlled and Open Study to Assess the Efficacy (Peritoneal Biocompatibility) of the Addition of Bemiparin to Icodextrin Solution in Patients in Peritoneal Dialysis With Peritoneal Transp

Brief Summary: The purpose of this study is to evaluate whether addition of bemiparin, once daily in icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients presenting functional disorders related to ultrafiltration deficit and/or high transport.

Detailed Summary: Peritoneal dysfunction is a common complication in patients in stable treatment with peritoneal dialysis. This peritoneal dysfunction is defined by an elevated creatinine transport and lowered standardized ultrafiltration capacity. The aim of this study is to evaluate the efficacy of the addition of bemiparin to icodextrin solution in patients in peritoneal dialysis with peritoneal transport disorders. The eligible patients are randomly assigned to receive the icodextrin solution with bemiparin or icodextrin solution without bemiparin.
Sponsor: Fundación Renal Iñigo Alvarez De Toledo

Current Primary Outcome: Efficacy: Peritoneal function defined according to the standardized ultrafiltration capacity and/or estimated peritoneal creatinine transport estimated by D/P and mass transfer coefficient during randomized treatment

Original Primary Outcome: Efficacy: Peritoneal function defined according to the standardized ultrafiltration capacity and/or estimated peritoneal creatinine transport estimated by D/P and mass transfer coefficient during randomized treatment.

Current Secondary Outcome: Safety: Incidence of peritonitis during the randomized treatment period, defined by a cell count of peritoneal effluent with more than 100 leukocytes per mm3 with 50% or more polymorphonuclear cells

Original Secondary Outcome: Safety:Incidence of peritonitis during the randomized treatment period, defined by a cell count of peritoneal effluent with more than 100 leukocytes per mm3 with 50% or more polymorphonuclear cells.

Information By: Fundación Renal Iñigo Alvarez De Toledo

Dates:
Date Received: August 28, 2006
Date Started: September 2006
Date Completion:
Last Updated: May 13, 2010
Last Verified: May 2010