Biological Determinants of Peritoneal Dialysis
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 10/26/2018 |
| Start Date: | September 15, 2015 |
| End Date: | November 2021 |
| Contact: | Rajnish Mehrotra, MD |
| Email: | rmehrotr@uw.edu |
| Phone: | 206-685-0567 |
Peritoneal Dialysis (PD) is a technique for treating kidney failure where fluid is instilled
into the body's peritoneal cavity. Fluid and solutes travel across the peritoneal membrane,
and the function of this membrane is critical to successful PD. Studies have shown that
certain demographic and clinical variables explain a very small part of the variability in
baseline function. This study will further explore the common genetic variants that determine
the baseline peritoneal membrane function in patients starting treatment with PD and change
in function upon treatment .
This study will incorporate data from subjects' first ever peritoneal equilibrium test (PET),
changes in the transfer of water across the peritoneal membrane over time, demographic
information, and results from laboratory analysis of DNA, blood, and dialysate. The
investigators hope that this study will provide information on the biological pathways that
account for variability in the peritoneal membrane. This could ultimately lead to the
development of biomarkers to identifying individuals at risk for decline in peritoneal
membrane function over time and/or be used to identify novel therapeutic targets to preserve
or enhance membrane function. Identifying the biological pathways will also increase the
understanding of vascular biology, angiogenesis, and fibrosis that could be applied to other
tissues and other diseases.
into the body's peritoneal cavity. Fluid and solutes travel across the peritoneal membrane,
and the function of this membrane is critical to successful PD. Studies have shown that
certain demographic and clinical variables explain a very small part of the variability in
baseline function. This study will further explore the common genetic variants that determine
the baseline peritoneal membrane function in patients starting treatment with PD and change
in function upon treatment .
This study will incorporate data from subjects' first ever peritoneal equilibrium test (PET),
changes in the transfer of water across the peritoneal membrane over time, demographic
information, and results from laboratory analysis of DNA, blood, and dialysate. The
investigators hope that this study will provide information on the biological pathways that
account for variability in the peritoneal membrane. This could ultimately lead to the
development of biomarkers to identifying individuals at risk for decline in peritoneal
membrane function over time and/or be used to identify novel therapeutic targets to preserve
or enhance membrane function. Identifying the biological pathways will also increase the
understanding of vascular biology, angiogenesis, and fibrosis that could be applied to other
tissues and other diseases.
This study will comprise of patient populations from pre-existing biorepositories and
prospectively enrolled subjects. DNA will be analyzed from cohorts with data and DNA already
collected and available, while prospective sites will collect plasma, DNA, and spent
dialysate for further analysis. Clinical data related to the subjects' first ever Peritoneal
Equilibrium Test (PET), demographic information, change in ultrafiltration capacity over
time, will be correlated with various genetic markers of interest.
Blood and dialysate will be collected at the first study visit, and there will be no
additional sample collection. These samples will be collected as part of a PET during a
standard of care study visit, or during a timed 4 hour dwell of 2.5% or 4.25% dextrose
solution. Annually, subjects will either undergo a PET as standard of care or perform an
additional 4 hour dwell as part of the study. These subsequent measures will be utilized to
determine change in ultrafiltration capacity over time.
This study has two specific aims:
Aim 1: To identify and validate genetic loci that influence the peritoneal solute transfer
rate (PSTR) at start of PD.
Aim 2: To identify and validate genetic loci in pre-specified biologic pathways with change
in peritoneal ultrafiltration capacity.
If subjects grant permission, Genome Wide Association Studies (GWAS) results may be
transferred to the NIH database of genotypes and phenotypes (dbGaP). Additionally, subjects
may agree that remaining samples will be maintained at the University of Washington Kidney
Research Institute in a repository for use in future research studies.
prospectively enrolled subjects. DNA will be analyzed from cohorts with data and DNA already
collected and available, while prospective sites will collect plasma, DNA, and spent
dialysate for further analysis. Clinical data related to the subjects' first ever Peritoneal
Equilibrium Test (PET), demographic information, change in ultrafiltration capacity over
time, will be correlated with various genetic markers of interest.
Blood and dialysate will be collected at the first study visit, and there will be no
additional sample collection. These samples will be collected as part of a PET during a
standard of care study visit, or during a timed 4 hour dwell of 2.5% or 4.25% dextrose
solution. Annually, subjects will either undergo a PET as standard of care or perform an
additional 4 hour dwell as part of the study. These subsequent measures will be utilized to
determine change in ultrafiltration capacity over time.
This study has two specific aims:
Aim 1: To identify and validate genetic loci that influence the peritoneal solute transfer
rate (PSTR) at start of PD.
Aim 2: To identify and validate genetic loci in pre-specified biologic pathways with change
in peritoneal ultrafiltration capacity.
If subjects grant permission, Genome Wide Association Studies (GWAS) results may be
transferred to the NIH database of genotypes and phenotypes (dbGaP). Additionally, subjects
may agree that remaining samples will be maintained at the University of Washington Kidney
Research Institute in a repository for use in future research studies.
Inclusion Criteria:
- Adults over the age of 20 who are able to provide consent
- Record of a PET within 6 months of starting PD treatment
Exclusion Criteria:
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