End Stage Renal DiseaseDelflexNCT01292863
The Impact of Delflex on Mesothelial Cell Viability and Peritoneal Transport
A study testing Active Comparator: Conventional peritoneal dialysis solution and Experimental: Novel biocompatible dialysis solution in people with End Stage Renal Disease, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Active Comparator: Conventional peritoneal dialysis solution and Experimental: Novel biocompatible dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
About this study
Official title: The Impact of a Biocompatible Peritoneal Dialysis Solution (Delflex Neutral pH) on Mesothelial Cell Viability and Peritoneal Transport
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.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Active Comparator: Conventional peritoneal dialysis solution, Experimental: Novel biocompatible dialysis solution
- Keywords
- Peritoneal dialysis, Biocompatible dialysis fluid
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Conventional peritoneal dialysis solutionOther
Also called Delflex
Daily dialysis solution to be used for 3 months in crossover fashion.
Experimental: Novel biocompatible dialysis solutionOther
Also called Delflex neutral pH
Daily dialysis solution to be used for 3 months in crossover fashion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Active Comparator: Conventional peritoneal dialysis solution |
| Novel biocompatible dialysis solution Delflex neutral pH | Experimental | Not described Receives: Other: Experimental: Novel biocompatible dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Cancer antigen 125 (CA 125) in spent dialysate
Cancer antigen 125 (CA 125) is a marker of mesothelial cell mass and studies have shown significantly increased levels of CA 125 utilizing novel biocompatible peritoneal dialysis solutions compared to conventional solutions. We plan to determine whether CA 125 correlate with effluent total and apoptotic mesothelial cells.
Measured: 6 months
Characterize the mesothelial transport of glucose degradation products (GDPs) and advanced advanced glycosylation end products (AGEs)
Theoretically, a promising benefit of utilizing the novel peritoneal dialysis solutions is the beneficial effect of reduced local and systemic damage secondary to advanced glycosylation products. A recent study found a significant decrease in circulating AGE levels in patients treated with low GDP solution over 3 months compared to levels after 3 months using standard peritoneal dialysis fluid. We plan to characterize the mesothelial transport of GDPs and AGEs after exposure to Delflex neutral pH solution versus conventional peritoneal dialysis solution.
Measured: 6 months
Connective tissue growth factor(CTGF)in spent dialysis fluid
Connective tissue growth factor (CTGF) levels in spent peritoneal dialysis fluid are strongly associated with high peritoneal solute transport rate and ultrafiltration failure. Connective tissue growth factor (CTFG) may be another marker of peritoneal membrane fibrosis and thus predictive of dialysis membrane failure. We plan to determine whether CTGF levels correlate with effluent total and apoptotic mesothelial cells.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012 (estimated)
- Study completionMay 2012 (estimated)
Why it stopped: Study was modified to in vitro design and no longer involves participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Principal investigator, Cindy Denu-Ciocca, MD, University of North Carolina, Chapel Hill
- Investigators
- Cynthia J Denu-Ciocca, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292863
- Sponsor's protocol ID
- 10-2359
- Acronym
- Delflex
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8706362Williams 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.
PubMed 11805177Williams 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.
PubMed 14870877Pajek 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.
PubMed 18178947Williams 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.
PubMed 15200450Theodoridis 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.
PubMed 18300115Kanjanabuch 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.
PubMed 18552238Zarrinkalam 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.
PubMed 12787426Mizutani 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.
PubMed 20015945Ishibashi 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.
PubMed 11929138Morgan 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.
PubMed 14531821Linden 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.
PubMed 9663893Thornalley PJ. Measurement of protein glycation, glycated peptides, and glycation free adducts. Perit Dial Int. 2005 Nov-Dec;25(6):522-33.
PubMed 16419322Li 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.
PubMed 14733914
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Biocompatible Peritoneal Dialysis Solution (Delflex Neutral pH) on Mesothelial Cell Viability and Peritoneal Transport
- ClinicalTrials.gov ID
- NCT01292863
- Acronym / sponsor ID
- Delflex / 10-2359
- Conditions
- End Stage Renal Disease
- Keywords
- Peritoneal dialysis, Biocompatible dialysis fluid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was modified to in vitro design and no longer involves participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional peritoneal dialysis solution | Active comparator | Other: Active Comparator: Conventional peritoneal dialysis solutionSubjects 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. |
| Novel biocompatible dialysis solution Delflex neutral pH | Experimental | Other: Experimental: Novel biocompatible dialysis solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Conventional peritoneal dialysis solutionAlso: DelflexDaily dialysis solution to be used for 3 months in crossover fashion. | Other | Conventional peritoneal dialysis solution |
| Experimental: Novel biocompatible dialysis solutionAlso: Delflex neutral pHDaily dialysis solution to be used for 3 months in crossover fashion. | Other | Novel biocompatible dialysis solution Delflex neutral pH |
Primary outcome
Mesothelial cell shedding and apoptosis
Time frame: 6 months
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
3 secondary outcomes
Cancer antigen 125 (CA 125) in spent dialysate
Time frame: 6 months
Characterize the mesothelial transport of glucose degradation products (GDPs) and advanced advanced glycosylation end products (AGEs)
Time frame: 6 months
Connective tissue growth factor(CTGF)in spent dialysis fluid
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 8706362Davies 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.
- Background: PubMed 11805177Williams 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.
- Background: PubMed 14870877Williams 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.
- Background: PubMed 18178947Pajek 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.
- Background: PubMed 15200450Williams 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.
- Background: PubMed 18300115Theodoridis 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.
- Background: PubMed 18552238Kanjanabuch 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.
- Background: PubMed 12787426Zarrinkalam 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.
- Background: PubMed 20015945Mizutani 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.
- Background: PubMed 11929138Ishibashi 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.
- Background: PubMed 14531821Morgan 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.
- Background: PubMed 9663893Linden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J Denu-Ciocca, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Conventional peritoneal dialysis solution and Experimental: Novel biocompatible dialysis solution in people with End Stage Renal Disease, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesothelial cell shedding and apoptosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292863, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.