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End Stage Renal DiseaseNCT02133313

Icodextrin Effects on Glucose Transporter Activation and Mediators of Fibrosis

An observational study of End Stage Renal Disease, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The time on peritoneal dialysis may be limited for a significant number of patients that use this modality of renal replacement therapy due to the inability of the peritoneal membrane to clear solutes or achieve adequate ultrafiltration, termed peritoneal membrane failure (PMF). Read more about this study

Who is it for?
Ages 19 to 100 years
Conditions the study is for
End Stage Renal Disease
How many people
49 participants
Where
1 siteUnited States
Study dates
May 2014to Mar 2017
How long will I take part?
3 Years
Phase
Observational
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 19 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients over the age of 19 on Peritoneal Dialysis at the University of Alabama at Birmingham

Who may be able to join

  • 19 years of age or older
  • On Peritoneal Dialysis

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham Home Dialysis Unit (Red Mountain Home Dialysis)

    Birmingham, Alabama, 35294

Other trials in United States

About this study

The time on peritoneal dialysis may be limited for a significant number of patients that use this modality of renal replacement therapy due to the inability of the peritoneal membrane to clear solutes or achieve adequate ultrafiltration, termed peritoneal membrane failure (PMF). This can be devastating for patients who have become accustomed to the quality of life provided by peritoneal dialysis and who otherwise have done well on this therapy. There is clinical evidence suggesting that icodextrin preserves the peritoneal membrane transport characteristics which may be linked to reduced cumulative glucose exposure of the peritoneal mesothelial cells. Theories to explain the role of dextrose in PMF have focused for the most part on the high intracellular concentrations of glucose without consideration to the potential pathogenic role of the glucose transporters which allow glucose entry into the cell. Experimental evidence in non-mesothelial cell lines indicate that some cellular processes that occur under high glucose conditions may not be related to intracellular glucose metabolism but to the type of glucose transporter allowing glucose entry. 3,4 However, little is known about these glucose transporters in peritoneal mesothelial cells and their potential role in the development of PMF.

We hypothesize the following

  • The presence of Sodium Glucose Co-transporter (SGLT1) on peritoneal mesothelial cells plays a role in PMF under hyperglycemic conditions.
  • Regulation of pro-fibrotic mediators such as reactive oxidative species,transforming growth factor β, and vascular endothelial growth factor are modulated by SGLT1 activation by glucose rather than glucose metabolism or concentration.
  • Icodextrin does not activate the SGLT1 transporter establishing a mechanism that may explain the beneficial effects of icodextrin on peritoneal membrane transport.
Read the detailed description

Participants enrolled in this study will have pertinent clinical information entered into a database. Participants will then have spent peritoneal dialysate collected at least every 6 months and analyzed for markers of fibrosis. Patients undergoing a special type of peritoneal dialysis start call urgent start peritoneal dialysis will have spent peritoneal dialysate collected more frequently at the start of peritoneal dialysis and then every 6 months. The results from the analysis of the peritoneal dialysate will then be correlated with data in the patient registry.

Quality assurance- As this is a single center trial all data will be monitored by the PI. Data will be entered in a prospective manner into the database by a research coordinator. Every 6 months data will be checked for accuracy by comparing to data collected for routine clinical purposes by both the home dialysis unit which tracks all hospitalizations, peritonitis, exit site infections, technique failures. As well as the dialysis access database maintained by the University of Alabama at Birmingham.

Source data verification- Data will come from both the history and physical of the primary investigator as well as electronic medical records at the University of Alabama at Birmingham and Falcon Electronic Health Record from Davita.

Data Dictionary is as follows. Variable / Field Name study_id Is the patient restarting Peritoneal dialysis after stopping If the patient is restarting are they restarting with the same catheter or a new catheter Date of 1st Access Length of time catheter placed prior to use How was the catheter placed: Surgically vs. Interventional Radiology Open versus laparoscopic Lysis of Adhesions Omentopexy Type of PD Catheter Has the patient had a second access procedure Medical Record Number Davita Medical Record Number Person Entering Data first_name last_name Date of Birth sex race address Is the patient new to dialysis? Has the patient previously been on peritoneal dialysis. transfer Why was peritoneal dialysis stopped. Type of Start: Urgent start versus traditional start Anuric Urgent Start: Inpatient or Outpatient Admit Date for PD Initiation Date of Discharge for pd initiation Did the patient require hemodialysis during urgent start period Indication for Hemodialysis Number of Hemodialysis sessions Nonsurgical catheter issues Date of PD start Age at PD start Date of PD graduation Length of time to PD graduation Reason for Urgent start PD first_dialysis_modality Predialysis education type_predialysis_education Glomerular filtration rate at time of PD start Has the patient stopped PD Did the patient stop Peritoneal dialysis or did they transfer out? Date PD was stopped Length of time on dialysis Age PD stopped Reason PD stopped When the patient transferred, did they transfer with an access or a permacath Cause of death Cause of End Stage Renal Disease (ESRD) Comorbidities Has the patient had a kidney transplant Previous abdominal surgeries? Type of previous abdominal surgeries height Indication for Peritoneal Equilibration Test (PET Date of PET Type of PET 2 hour D/P Creatinine 4 hour D/P Creatinine Transporter type 2 hour D/D0 Glucose 4 hour D/D0 Glucose Initial PET glucose PD Glucose 4 hours Glucose Absorption PET Drain Volume Ultrafiltration PD Sodium 0 Hour PD Sodium 1 Hour PD Sodium 2 hour PD Sodium 4 Hour Serum Sodium Minimum PD Sodium Level Systolic Blood Pressure Diastolic Blood Pressure Mean Arterial Pressure Weight Body Mass Index Hemoglobin Albumin Ferritin Iron Transferrin Saturation Hemoglobin A1c Creatinine Potassium BUN Sodium Hco3 Total Protein total cholesterol HDL LDL Vitamin D 25 Phosphorus Calcium PTH Kt/V Does the patient have a last fill Icodextrin versus dianeal Midday Total Liters per day Total Liters Total 6 month glucose exposure Is the patient on icodextrin Date of Icodextrin start Length of time on icodextrin Kt/v prior to icodextrin Kt/V after icodextrin Reason icodextrin stopped Date Icodextrin stopped Length of time on icodextrin Has the patient had peritonitis Date of infection Polymicrobial Pathogen Gram Positive Methicillin Resistant Gram Negative Ciprofloxacin Resistant Fungal Did the patient have antibiotics prior to fungal peritonitis What antibiotic Did the patient receive fungal prophylaxis Is this relapsing or recurrent Has the patient been hospitalized Date of admission Length of time to first admission Date of Discharge Length of stay Reason for admit Hospitalization Outcome Cause of death

Standard Operating Procedures: Patient recruitment will be from the University of Alabama at Birmingham Home Dialysis unit.

Sample size: As there are no data on which to base the power calculation for this unique study on glucose transporters and their role in peritoneal membrane fibrosis, descriptive statistics will be used to gain insight into the proposed research questions. Continuous variables will be summarized with mean and standard deviation or median and interquartile range depending on the distribution. Categorical variables will be summarized with frequency and percentage.

Keywords
Peritoneal Dialysis, Peritoneal Fibrosis, Glucose Transporters
Medical subject headings
Kidney Failure, Chronic, Peritoneal Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02133313
Study groupRoleWhat they receive
Peritoneal Dialysis PatientsPatients on Peritoneal Dialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glucose transporter expression on peritoneal mesothelial cells

    Measured: baseline to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
49 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133313
Sponsor's protocol ID
ICO-X140206005
Status last verified
Apr 2017
First submitted
30 Apr 2014
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Davies SJ, Phillips L, Naish PF, Russell GI. Peritoneal glucose exposure and changes in membrane solute transport with time on peritoneal dialysis. J Am Soc Nephrol. 2001 May;12(5):1046-1051. doi: 10.1681/ASN.V1251046.

    PubMed 11316864
  • Davies SJ, Brown EA, Frandsen NE, Rodrigues AS, Rodriguez-Carmona A, Vychytil A, Macnamara E, Ekstrand A, Tranaeus A, Filho JC; EAPOS Group. Longitudinal membrane function in functionally anuric patients treated with APD: data from EAPOS on the effects of glucose and icodextrin prescription. Kidney Int. 2005 Apr;67(4):1609-15. doi: 10.1111/j.1523-1755.2005.00243.x.

    PubMed 15780118
  • Balteau M, Tajeddine N, de Meester C, Ginion A, Des Rosiers C, Brady NR, Sommereyns C, Horman S, Vanoverschelde JL, Gailly P, Hue L, Bertrand L, Beauloye C. NADPH oxidase activation by hyperglycaemia in cardiomyocytes is independent of glucose metabolism but requires SGLT1. Cardiovasc Res. 2011 Nov 1;92(2):237-46. doi: 10.1093/cvr/cvr230. Epub 2011 Aug 22.

    PubMed 21859816
  • Palazzo M, Gariboldi S, Zanobbio L, Selleri S, Dusio GF, Mauro V, Rossini A, Balsari A, Rumio C. Sodium-dependent glucose transporter-1 as a novel immunological player in the intestinal mucosa. J Immunol. 2008 Sep 1;181(5):3126-36. doi: 10.4049/jimmunol.181.5.3126.

    PubMed 18713983
  • Schroppel B, Fischereder M, Wiese P, Segerer S, Huber S, Kretzler M, Heiss P, Sitter T, Schlondorff D. Expression of glucose transporters in human peritoneal mesothelial cells. Kidney Int. 1998 May;53(5):1278-87. doi: 10.1046/j.1523-1755.1998.00899.x.

    PubMed 9573543
  • Fischereder M, Schroppel B, Wiese P, Fink M, Banas B, Schmidbauer S, Schlondorff D. Regulation of glucose transporters in human peritoneal mesothelial cells. J Nephrol. 2003 Jan-Feb;16(1):103-9.

    PubMed 12649541

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease, run by University of Alabama at Birmingham at 1 site in United States.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in glucose transporter expression on peritoneal mesothelial cells (time frame: baseline to 3 years). 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 NCT02133313, which also lists 6 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 19 Apr 2017.

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