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Biological Determinants of Peritoneal Dialysis


Title Biological Determinants of Peritoneal Dialysis
Therapeutic Area Renal Disease
Principal Investigator Daniel Weiner, MD MS
Min Age 20 Years
Gender All
Contact Eamon Fleming
617 636 5895
More Information https://clinicaltrials.gov/ct2/show/NCT02694068

Overview

In people with kidney failure, water and many different types of toxins build up in the body. In the process of peritoneal dialysis (PD), water and toxins are moved from the blood across the lining of the abdomen into the dialysis fluid so that they can be removed from the body, since the kidneys can no longer perform this job on their own. The lining of the abdomen is called the peritoneal membrane. Previous studies have shown that different people react differently to the process of PD. In some people, toxins move faster across the peritoneal membrane than in others. Similarly, in some people, more water crosses the peritoneal membrane than in others. Also, in some people treated with PD, the amount of water that crosses the peritoneal membrane decreases with time. All of these differences can affect how well people tolerate receiving PD. In this study, we want to find out if these differences we observe in how the peritoneal membrane works depend upon the genes that different people inherit (i.e., the DNA with which people are born).

This study will be conducted at Dialysis Clinic Inc. (DCI) Somerville. Up to 100 subjects will be enrolled at DCI Somerville. All sample and data analysis will be performed at the University of Washington in Seattle. This study is funded by a grant from the National Institute of Health.

We would like to collect a sample of your blood to obtain your DNA and plasma. Further, we would like to get information from a sample of your dialysis fluid and your medical records related to how much and how quickly toxins and water transfer across your peritoneal membrane. By comparing any changes in these transfers as you continue with PD treatment, we would like to identify factors that might be contributing to the decrease in the amount of water being transferred during dialysis in some people. To identify these factors, we may look at your unique genetic information in many ways. Some methods look only for specific portions of your DNA, while other methods “read” or sequence much larger portions (the exome) of DNA. We may also use your sample to look at the entire sequence of your DNA, which is called the genome. One technique, the Genome Wide Association Studies (GWAS), compares sequence patterns in genomes from different people.

Study Details

Inclusion Criteria

  • Dialysis patient at DCI Somerville
  • 20 years of age or older
  • Must have on record a peritoneal equilibration test (PET) result from within six months of the initiation date of their dialysis treatment (determined by simple review of medical records)
  • Competent and willing to provide informed consent

Exclusion Criteria

  • Significant concerns about participation from family members
  • Lack of support from primary health care provider
  • Clinical diagnosis of dementia
  • Treatment with medications for dementia
  • Behavioral factors that in the judgment of the Principal Investigator may interfere with adherence

Study Requirements

If you agree to take part in the study, the dialysis facility at DCI Somerville will give us access to information about your peritoneal membrane function during dialysis. This information is collected in a routine dialysis clinic test called the Peritoneal Equilibration Test (PET). You may have had a PET done when you first started PD and at other times since then. At DCI Somerville, new PD patients typically undergo a PET within the first few months of dialysis, and periodically thereafter. If your dialysis facility plans on doing a PET as part of your regular care within the next 12 months, we will collect data and/or samples from your regularly scheduled clinical PET. If you do not have a PET scheduled in the next 12 months, we will then have a separate PET test set up, which will be for research purposes only.

During your PET test, you will drain the fluid from your peritoneal cavity and instill approximately 2 liters of dialysis fluid (dextrose solution) into your stomach (peritoneum). After about 4 hours, we will drain it. We will weigh the bag, measure the volume, and collect one 50ml tube of this dialysate fluid. Additionally, at the midpoint of the dwell (after about 2 hours), we will collect 2 tubes of blood sample from you (10mL in each tube, for a total of about 4 teaspoons of blood). We will also measure and record the amount of water that comes out with the dialysis fluid. These samples of blood and dialysis fluid will typically be sent to the local laboratory for testing.

Donation of these blood and dialysate samples is an optional component of this study, and you may participate in the study without agreeing to donate these samples for banking. You will receive the same treatment and care whether or not you decide to donate these samples for this study.

We will repeat this PET test procedure annually, assuming you are still undergoing PD, for a maximum of 3 years. However, collection of blood and dialysis fluid samples for research purposes will only occur at this initial test.

The study team will also collect information from your medical record, including data concerning your dialysis treatment, medical condition, laboratory values, medications, hospitalizations, and other aspects of your medical care. This information will be used as a part of the genetic analyses conducted for this study.