End-Stage Kidney DiseaseBio-PDNCT02694068
Biological Determinants of Peritoneal Dialysis
An observational study of End-Stage Kidney Disease, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- Peritoneal Equilibrium Test and 4 hour dwell of 2.5/4.25% dextrose solution
- How many people
- 4,865 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2015to 1 Aug 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing maintenance Peritoneal Dialysis therapy.
Who may be able to join
- Adults over the age of 20 who are able to provide consent
- Record of a PET within 6 months of starting PD treatment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- Peritoneal Equilibrium Test, 4 hour dwell of 2.5/4.25% dextrose solution
- Keywords
- Peritoneal Dialysis, Genetic, Peritoneal Membrane, Peritoneal Equilibrium Test, Ultrafiltration Capacity, End Stage Renal Disease (ESRD)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Equilibrium TestOther
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 solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Discovery for Aim One | 2173 subjects will be involved in the discovery cohort. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Peritoneal Equilibrium Test; Other: 4 hour dwell of 2.5/4.25% dextrose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-hour Dialysate to Plasma ratio of creatinine
From Peritoneal Equilibration Test performed at the time of start of PD
Measured: 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.
Measured: Once per year (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start15 Sep 2015
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 4,865 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajnish Mehrotra, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694068
- Sponsor's protocol ID
- STUDY00002027
- Acronym
- Bio-PD
- Status last verified
- Dec 2021
- First submitted
- 12 Feb 2016
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40669005
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Determinants of Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02694068
- Acronym / sponsor ID
- Bio-PD / STUDY00002027
- Conditions
- End-Stage Kidney Disease
- Keywords
- Peritoneal Dialysis, Genetic, Peritoneal Membrane, Peritoneal Equilibrium Test, Ultrafiltration Capacity, End Stage Renal Disease (ESRD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,865 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Discovery for Aim One | – | Other: Peritoneal Equilibrium Test, Other: 4 hour dwell of 2.5/4.25% dextrose solution2173 subjects will be involved in the discovery cohort. |
| Replication for Aim One | – | Other: Peritoneal Equilibrium Test, Other: 4 hour dwell of 2.5/4.25% dextrose solution1673 subjects will comprise the replication cohort. |
| Discovery for Aim Two | – | Other: Peritoneal Equilibrium Test, Other: 4 hour dwell of 2.5/4.25% dextrose solution824 subjects will be involved in the discovery cohort. |
| Replication for Aim Two | – | Other: Peritoneal Equilibrium Test, Other: 4 hour dwell of 2.5/4.25% dextrose solution538 subjects will comprise the replication cohort. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing maintenance Peritoneal Dialysis therapy.
Key inclusion criteria (2 listed)
- Adults over the age of 20 who are able to provide consent
- Record of a PET within 6 months of starting PD treatment
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal Equilibrium TestThese will be done as part of standard of care procedures. PETs will not be performed solely for research purposes. | Other | 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 solutionIf 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. | Other | Discovery for Aim One, Discovery for Aim Two, Replication for Aim One, Replication for Aim Two |
Primary outcome
Four-hour Dialysate to Plasma ratio of creatinine
Time frame: Prior to study participation or within 6 months of enrollment
From Peritoneal Equilibration Test performed at the time of start of PD
Change in peritoneal ultrafiltration capacity over time
Time frame: Once per year (up to 3 years)
This will be determined from annual assessments of the peritoneal ultrafiltration capacity with a four-hour timed dwell with 4.25%/2.5% dextrose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Derived from this study: PubMed 40669005Stanaway 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-Stage Kidney Disease, run by University of Washington 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 10 Dec 2021. 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?
Four-hour Dialysate to Plasma ratio of creatinine (time frame: Prior to study participation or within 6 months of enrollment). The study lists 2 primary outcomes in all. 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 NCT02694068, which also lists 1 linked publication.
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 10 Dec 2021.