The Impact of Delflex on Mesothelial Cell Viability and Peritoneal Transport

NCT01292863 | Withdrawn

• 1 other identifier: 10-2359
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

Peritoneal dialysis; Biocompatible dialysis fluid

Outcome Measures

Primary Outcomes (1)

• Mesothelial cell shedding and apoptosis

  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

  6 months

Secondary Outcomes (3)

• Cancer antigen 125 (CA 125) in spent dialysate

  6 months

• Characterize the mesothelial transport of glucose degradation products (GDPs) and advanced advanced glycosylation end products (AGEs)

  6 months

• Connective tissue growth factor(CTGF)in spent dialysis fluid

  6 months

Study Arms (2)

Conventional peritoneal dialysis solution

ACTIVE COMPARATOR

Subjects will be randomized to perform dialysis with the conventional peritoneal dialysis solution for 3 months. At the end of three months mesothelial cell shedding and apoptosis will be measured.

Other: Active Comparator: Conventional peritoneal dialysis solution

Novel biocompatible dialysis solution Delflex neutral pH

EXPERIMENTAL

Other: Experimental: Novel biocompatible dialysis solution

Interventions

Active Comparator: Conventional peritoneal dialysis solution OTHER

Daily dialysis solution to be used for 3 months in crossover fashion.

Also known as: Delflex

Conventional peritoneal dialysis solution

Experimental: Novel biocompatible dialysis solution OTHER

Daily dialysis solution to be used for 3 months in crossover fashion.

Also known as: Delflex neutral pH

Novel biocompatible dialysis solution Delflex neutral pH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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 dialysis)
• Patients must maintain modality of either CAPD or CCPD throughout duration of study
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Fresenius Medical Care North America: collaborator

Related Publications (14)

• Davies SJ, Russell L, Bryan J, Phillips L, Russell GI. Impact of peritoneal absorption of glucose on appetite, protein catabolism and survival in CAPD patients. Clin Nephrol. 1996 Mar;45(3):194-8.

  PMID: 8706362 BACKGROUND

• Williams JD, Craig KJ, Topley N, Von Ruhland C, Fallon M, Newman GR, Mackenzie RK, Williams GT. Morphologic changes in the peritoneal membrane of patients with renal disease. J Am Soc Nephrol. 2002 Feb;13(2):470-479. doi: 10.1681/ASN.V132470.

  PMID: 11805177 BACKGROUND

• Williams JD, Craig KJ, von Ruhland C, Topley N, Williams GT; Biopsy Registry Study Group. The natural course of peritoneal membrane biology during peritoneal dialysis. Kidney Int Suppl. 2003 Dec;(88):S43-9. doi: 10.1046/j.1523-1755.2003.08805.x. No abstract available.

  PMID: 14870877 BACKGROUND

• Pajek J, Kveder R, Bren A, Gucek A, Ihan A, Osredkar J, Lindholm B. Short-term effects of a new bicarbonate/lactate-buffered and conventional peritoneal dialysis fluid on peritoneal and systemic inflammation in CAPD patients: a randomized controlled study. Perit Dial Int. 2008 Jan-Feb;28(1):44-52.

  PMID: 18178947 BACKGROUND

• Williams JD, Topley N, Craig KJ, Mackenzie RK, Pischetsrieder M, Lage C, Passlick-Deetjen J; Euro Balance Trial Group. The Euro-Balance Trial: the effect of a new biocompatible peritoneal dialysis fluid (balance) on the peritoneal membrane. Kidney Int. 2004 Jul;66(1):408-18. doi: 10.1111/j.1523-1755.2004.00747.x.

  PMID: 15200450 BACKGROUND

• Theodoridis M, Passadakis P, Kriki P, Gioka T, Panagoutsos S, Mourvati E, Thodis E, Kantartzi K, Vargemezis V. The alteration of dialysate cancer antigen 125 concentration under a biocompatible bicarbonate peritoneal dialysis solution and the preservation of the mesothelial cell viability. Ren Fail. 2008;30(2):161-7. doi: 10.1080/08860220701808384.

  PMID: 18300115 BACKGROUND

• Kanjanabuch T, Siribamrungwong M, Khunprakant R, Kanjanabuch S, Jeungsmarn P, Achavanuntakul B, Pongpirul K, Park MS, Tungsanga K, Eiam-Ong S. Overnight mesothelial cell exfoliation: a magic tool for predicting future ultrafiltration failure in patients on continuous ambulatory peritoneal dialysis. Perit Dial Int. 2008 Jun;28 Suppl 3:S107-13.

  PMID: 18552238 BACKGROUND

• Zarrinkalam KH, Stanley JM, Gray J, Oliver N, Faull RJ. Connective tissue growth factor and its regulation in the peritoneal cavity of peritoneal dialysis patients. Kidney Int. 2003 Jul;64(1):331-8. doi: 10.1046/j.1523-1755.2003.00069.x.

  PMID: 12787426 BACKGROUND

• Mizutani M, Ito Y, Mizuno M, Nishimura H, Suzuki Y, Hattori R, Matsukawa Y, Imai M, Oliver N, Goldschmeding R, Aten J, Krediet RT, Yuzawa Y, Matsuo S. Connective tissue growth factor (CTGF/CCN2) is increased in peritoneal dialysis patients with high peritoneal solute transport rate. Am J Physiol Renal Physiol. 2010 Mar;298(3):F721-33. doi: 10.1152/ajprenal.00368.2009. Epub 2009 Dec 16.

  PMID: 20015945 BACKGROUND

• Ishibashi Y, Sugimoto T, Ichikawa Y, Akatsuka A, Miyata T, Nangaku M, Tagawa H, Kurokawa K. Glucose dialysate induces mitochondrial DNA damage in peritoneal mesothelial cells. Perit Dial Int. 2002 Jan-Feb;22(1):11-21.

  PMID: 11929138 BACKGROUND

• Morgan LW, Wieslander A, Davies M, Horiuchi T, Ohta Y, Beavis MJ, Craig KJ, Williams JD, Topley N. Glucose degradation products (GDP) retard remesothelialization independently of D-glucose concentration. Kidney Int. 2003 Nov;64(5):1854-66. doi: 10.1046/j.1523-1755.2003.00265.x.

  PMID: 14531821 BACKGROUND

• Linden T, Forsback G, Deppisch R, Henle T, Wieslander A. 3-Deoxyglucosone, a promoter of advanced glycation end products in fluids for peritoneal dialysis. Perit Dial Int. 1998 May-Jun;18(3):290-3.

  PMID: 9663893 BACKGROUND

• Thornalley PJ. Measurement of protein glycation, glycated peptides, and glycation free adducts. Perit Dial Int. 2005 Nov-Dec;25(6):522-33.

  PMID: 16419322 BACKGROUND

• Li W, Hamada Y, Nakashima E, Naruse K, Kamiya H, Akiyama N, Hirooka H, Takahashi N, Horiuchi S, Hotta N, Oiso Y, Nakamura J. Suppression of 3-deoxyglucosone and heparin-binding epidermal growth factor-like growth factor mRNA expression by an aldose reductase inhibitor in rat vascular smooth muscle cells. Biochem Biophys Res Commun. 2004 Feb 6;314(2):370-6. doi: 10.1016/j.bbrc.2003.12.095.

  PMID: 14733914 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia J Denu-Ciocca, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 10, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2013-02