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The Impact of a Biocompatible Peritoneal Dialysis Solution (Delflex Neutral pH) on Mesothelial Cell Viability and Peritoneal Transport

18 Years
Not Enrolling
End Stage Renal Disease

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Trial Information

The Impact of a Biocompatible Peritoneal Dialysis Solution (Delflex Neutral pH) on Mesothelial Cell Viability and Peritoneal Transport

In spite of its benefits, many peritoneal dialysis patients ultimately have to switch
dialysis therapy to hemodialysis secondary to technique failure. Numerous etiologies for
peritoneal dialysis treatment failure exist and include the continuous exposure of the
peritoneal membrane to bioincompatible dialysis solutions with acidic pH and high content of
glucose degradation products. These factors have been implicated in mesothelial cell loss,
fibrosis and neovascularization, resulting in alterations in solute transport and
ultrafiltration failure. Novel peritoneal dialysis solutions with neutral pH and low
concentrations of glucose degradation products have recently been developed to improve
biocompatibility and ameliorate the consequences of membrane damage with conventional
peritoneal dialysis solutions. While novel peritoneal dialysis solutions have been
available outside the United States for several years, Delflex Neutral pH has only recently
been approved for use in the United States. Thus, the majority of all the data supporting
the benefits of these novel solutions comes from locations outside of the United States.

The central question regarding the novel peritoneal dialysis solution is whether long term
use will result in better preservation of the peritoneal membrane to support dialysis.
Ultimately, this can only be determined with studies comparing long term outcomes of
patients using the various solutions. However, given the expected availability in the United
States and the potential benefits of the novel peritoneal dialysis solutions long term
studies comparing outcomes with conventional solutions raises ethical concerns. Therefore,
surrogate markers for peritoneal membrane integrity are necessary. Short term studies using
various surrogate markers to assess mesothelial cell mass and peritoneal inflammation such
as Cancer Antigen 125 (CA125) and pro-inflammatory cytokines have been reported, but it is
uncertain how well these markers predict long term outcome. Recently, a novel approach to
predict outcome has been reported, using mesothelial cell shedding and apoptosis. The number
of mesothelial cells and the number of apoptotic mesothelial cells in a standard 8 hour
dialysis dwell were reported to correlate well with deterioration of peritoneal dialysis
characteristics over a one year follow-up. The authors concluded that mesothelial cell
shedding and apoptosis are reliable predictors of peritoneal membrane deterioration.

The purpose of this study is to evaluate the impact of Delflex neutral pH (a biocompatible
peritoneal dialysis solution) on mesothelial cell viability and peritoneal transport. The
study will specifically compare mesothelial cell shedding and apoptosis in the peritoneal
dialysis effluent after exposure to Delflex neutral pH solution and conventional peritoneal
dialysis solution. Cancer Antigen 125 (CA125)levels (indicative of mesothelial cell mass)
and connective tissue growth factor (CTGF) levels (a marker of inflammation) will be
measured in the spent dialysate to determine whether these markers correlate with cell
shedding and apoptosis. The study will also characterize the transport of glucose
degradation products (GDPs) and advanced glycosylation end products (AGEs) across the
mesothelial cells after exposure to Delflex neutral pH solution versus conventional
peritoneal dialysis solution.

Inclusion Criteria:

- ≥ 18 years of age

- Incident or prevalent patients with End Stage Kidney disease treated with either CAPD
(continuous ambulatory peritoneal dialysis) or CCPD (continuous cycling peritoneal

- Patients must maintain modality of either CAPD or CCPD throughout duration of study

- Able to provide informed consent

Exclusion Criteria:

- Pregnant or lactating women

- Recent (< 3 months) history of peritonitis

- CCPD utilizing Baxter cycler (due to inability to connect Delflex solution to cycler)

- Anticipated renal transplant within 6 months of enrollment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mesothelial cell shedding and apoptosis

Outcome Description:

Mesothelial cell shedding has been recently reported to predict deterioration of the peritoneal membrane.The novel peritoneal dialysis solution, Delflex neutral pH solution may decrease peritoneal inflammatory response resulting in less mesothelial cell shedding and apoptosis in the peritoneal dialysis effluent compared to use with standard peritoneal dialysate. The primary specific aim of the current project is to compare the effect of Delflex neutral pH solution with conventional dialysis solution on mesothelial cell shedding and apoptosis

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Cynthia J Denu-Ciocca, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

May 2012

Related Keywords:

  • End Stage Renal Disease
  • Peritoneal dialysis
  • Biocompatible dialysis fluid
  • Kidney Diseases
  • Kidney Failure, Chronic