Biological Determinants of Peritoneal Dialysis

NCT02694068 | Completed

• 1 other identifier: STUDY00002027
• Study Type: observational
• Target: 4,865
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-Stage Kidney Disease

Keywords

Peritoneal Dialysis; Genetic; Peritoneal Membrane; Peritoneal Equilibrium Test; Ultrafiltration Capacity; End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (2)

• Four-hour Dialysate to Plasma ratio of creatinine

  From Peritoneal Equilibration Test performed at the time of start of PD

  Prior to study participation or within 6 months of enrollment

• Change in peritoneal ultrafiltration capacity over time

  This will be determined from annual assessments of the peritoneal ultrafiltration capacity with a four-hour timed dwell with 4.25%/2.5% dextrose.

  Once per year (up to 3 years)

Study Arms (4)

Discovery for Aim One

2173 subjects will be involved in the discovery cohort.

Other: Peritoneal Equilibrium Test; Other: 4 hour dwell of 2.5/4.25% dextrose solution

Replication for Aim One

1673 subjects will comprise the replication cohort.

Other: Peritoneal Equilibrium Test; Other: 4 hour dwell of 2.5/4.25% dextrose solution

Discovery for Aim Two

824 subjects will be involved in the discovery cohort.

Other: Peritoneal Equilibrium Test; Other: 4 hour dwell of 2.5/4.25% dextrose solution

Replication for Aim Two

538 subjects will comprise the replication cohort.

Other: Peritoneal Equilibrium Test; Other: 4 hour dwell of 2.5/4.25% dextrose solution

Interventions

Peritoneal Equilibrium Test OTHER

These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.

Discovery for Aim One; Discovery for Aim Two; Replication for Aim One; Replication for Aim Two

4 hour dwell of 2.5/4.25% dextrose solution OTHER

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 One; Discovery for Aim Two; Replication for Aim One; Replication for Aim Two

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing maintenance Peritoneal Dialysis therapy.

You may qualify if:

• Adults over the age of 20 who are able to provide consent
• Record of a PET within 6 months of starting PD treatment

You may not qualify if:

• None

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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. 2026 Jan 1;37(1):49-66. doi: 10.1681/ASN.0000000803. Epub 2025 Jul 16.

  PMID: 40669005 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Dialysate, and DNA may be collected

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rajnish Mehrotra, MD. Professor of Medicine, Division of Nephrology, University of Washington

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 29, 2016
• Study Start: September 15, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)