Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4865 participants
OBSERVATIONAL
2015-09-15
2019-08-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Discovery for Aim One
2173 subjects will be involved in the discovery cohort.
Peritoneal Equilibrium Test
These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
4 hour dwell of 2.5/4.25% dextrose solution
If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
Replication for Aim One
1673 subjects will comprise the replication cohort.
Peritoneal Equilibrium Test
These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
4 hour dwell of 2.5/4.25% dextrose solution
If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
Discovery for Aim Two
824 subjects will be involved in the discovery cohort.
Peritoneal Equilibrium Test
These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
4 hour dwell of 2.5/4.25% dextrose solution
If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
Replication for Aim Two
538 subjects will comprise the replication cohort.
Peritoneal Equilibrium Test
These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
4 hour dwell of 2.5/4.25% dextrose solution
If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
Interventions
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Peritoneal Equilibrium Test
These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
4 hour dwell of 2.5/4.25% dextrose solution
If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
Eligibility Criteria
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Inclusion Criteria
* Record of a PET within 6 months of starting PD treatment
Exclusion Criteria
20 Years
ALL
No
Sponsors
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University of Washington
OTHER
Responsible Party
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Rajnish Mehrotra
Dr. Rajnish Mehrotra, MD. Professor of Medicine, Division of Nephrology, University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Stanaway IB, Costa IPD, Davies SJ, Perl J, Lambie M, Morelle J, Jarvik GP, Jain AK, Himmelfarb J, Heimburger O, Johnson DW, Pirkle J, Robinson B, Stenvinkel P, Yee-Moon Wang A, Devuyst O, Mehrotra R; Bio-PD Consortium. Genetic Variation and Ultrafiltration with Peritoneal Dialysis: A Genome-Wide Association Study. J Am Soc Nephrol. 2025 Jul 16. doi: 10.1681/ASN.0000000803. Online ahead of print. No abstract available.
Other Identifiers
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STUDY00002027
Identifier Type: -
Identifier Source: org_study_id