Peritoneal Dialysis ComplicationNCT03458819
EMT in Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis Complication, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Approximately 10-11% of end stage kidney disease patients worldwide utilize peritoneal dialysis (PD) as their method of renal replacement therapy. Over time, the peritoneal membrane often undergoes anatomic and functional changes due to the process of epithelial to mesenchymal transition (EMT). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peritoneal Dialysis Complication
- What is being tested?
- Isolation of peritoneal mesothelial cells
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 22 May 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients > 18 years old. We propose to study 4 groups of 6 patients each: 1. Patients taking neither an active Vitamin D analogue nor a statin 2. Patients already taking an active Vitamin D analogue 3. Patients already taking a statin 4. Patients already taking both an active Vitamin D analogue and a statin
Who may be able to join
- Patients > 18 years of age
- Patients on Peritoneal dialysis, and
- Patients that meet at least one of the criteria noted in the Population Description.
Who cannot join
- Patients with Recent peritonitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Epithelial to Mesenchymal Transition (EMT) in Peritoneal Dialysis Patients
Approximately 10-11% of end stage kidney disease patients worldwide utilize peritoneal dialysis (PD) as their method of renal replacement therapy. Over time, the peritoneal membrane often undergoes anatomic and functional changes due to the process of epithelial to mesenchymal transition (EMT). EMT is characterized by increases in pro-inflammatory and pro-angiogenic cytokines. In this process, the mesothelial cells lining the peritoneal membrane are denuded and change their morphology to one more closely resembling fibroblasts. These fibroblasts invade the submesothelial zone of the peritoneal membrane resulting in marked fibrosis, and the pro-angiogenic cytokines cause an increase in neovascularization. Jointly, these processes culminate in impaired function of the peritoneal membrane and often limit the duration of effective PD therapy.
In vitro studies in cultured human peritoneal mesothelial cells (HPMCs) and in vivo studies in rodent models of PD have demonstrated that the use of active Vitamin D receptor agonists or statins may attenuate this process of EMT. These are both classes of drugs that are commonly in use by patients on PD. The investigators goal is to determine whether either or both of these drugs might attenuate the process of EMT in patients performing PD.
Read the detailed description
Patients will perform a standard 2 Liter overnight dwell with the usual 2.5% dextrose PD solution. This will be done the night before a routinely scheduled visit to the home dialysis clinic. In the clinic the fluid will be drained in usual fashion and the fluid- which would otherwise be discarded- will be analyzed as below:
HPMCs will be isolated as previously described by Kinashi et al. and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, alpha smooth muscle actin (a-SMA), Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
- Conditions
- Peritoneal Dialysis Complication
- Being tested
- Isolation of peritoneal mesothelial cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of peritoneal mesothelial cellsDiagnostic test
HPMCs will be isolated and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients on neither active Vitamin D or a statin Receives: Diagnostic Test: Isolation of peritoneal mesothelial cells | |
| Vit D | Patients on active Vitamin D but not a statin Receives: Diagnostic Test: Isolation of peritoneal mesothelial cells | |
| Statin | Patients on a statin but not active Vitamin D Receives: Diagnostic Test: Isolation of peritoneal mesothelial cells | |
| D + Statin | Patients on both active Vitamin D and a statin Receives: Diagnostic Test: Isolation of peritoneal mesothelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the protein expression of EMT markers
The goal of this study is to determine whether either or both of these drugs, Vitamin D receptor agonists or statins, might attenuate the process of EMT in peritoneal mesothelial cells. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
Measured: One year or at the end of the study, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start20 Mar 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Teitelbaum, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458819
- Sponsor's protocol ID
- 18-0401
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epithelial to Mesenchymal Transition (EMT) in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03458819
- Acronym / sponsor ID
- 18-0401
- Conditions
- Peritoneal Dialysis Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 8 Mar 2018 (actual)
- 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.
Approximately 10-11% of end stage kidney disease patients worldwide utilize peritoneal dialysis (PD) as their method of renal replacement therapy. Over time, the peritoneal membrane often undergoes anatomic and functional changes due to the process of epithelial to mesenchymal transition (EMT). EMT is characterized by increases in pro-inflammatory and pro-angiogenic cytokines. In this process, the mesothelial cells lining the peritoneal membrane are denuded and change their morphology to one more closely resembling fibroblasts. These fibroblasts invade the submesothelial zone of the peritoneal membrane resulting in marked fibrosis, and the pro-angiogenic cytokines cause an increase in neovascularization. Jointly, these processes culminate in impaired function of the peritoneal membrane and often limit the duration of effective PD therapy.
In vitro studies in cultured human peritoneal mesothelial cells (HPMCs) and in vivo studies in rodent models of PD have demonstrated that the use of active Vitamin D receptor agonists or statins may attenuate this process of EMT. These are both classes of drugs that are commonly in use by patients on PD. The investigators goal is to determine whether either or both of these drugs might attenuate the process of EMT in patients performing PD.
Detailed description
Patients will perform a standard 2 Liter overnight dwell with the usual 2.5% dextrose PD solution. This will be done the night before a routinely scheduled visit to the home dialysis clinic. In the clinic the fluid will be drained in usual fashion and the fluid- which would otherwise be discarded- will be analyzed as below:
HPMCs will be isolated as previously described by Kinashi et al. and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, alpha smooth muscle actin (a-SMA), Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Isolation of peritoneal mesothelial cellsPatients on neither active Vitamin D or a statin |
| Vit D | – | Diagnostic Test: Isolation of peritoneal mesothelial cellsPatients on active Vitamin D but not a statin |
| Statin | – | Diagnostic Test: Isolation of peritoneal mesothelial cellsPatients on a statin but not active Vitamin D |
| D + Statin | – | Diagnostic Test: Isolation of peritoneal mesothelial cellsPatients on both active Vitamin D and a statin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients > 18 years old. We propose to study 4 groups of 6 patients each: 1. Patients taking neither an active Vitamin D analogue nor a statin 2. Patients already taking an active Vitamin D analogue 3. Patients already taking a statin 4. Patients already taking both an active Vitamin D analogue and a statin
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Patients on Peritoneal dialysis, and
- Patients that meet at least one of the criteria noted in the Population Description.
Key exclusion criteria (1 listed)
- Patients with Recent peritonitis
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 |
|---|---|---|
| Isolation of peritoneal mesothelial cellsHPMCs will be isolated and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis. | Diagnostic test | Control, D + Statin, Statin, Vit D |
Primary outcome
Changes in the protein expression of EMT markers
Time frame: One year or at the end of the study, whichever occurs first.
The goal of this study is to determine whether either or both of these drugs, Vitamin D receptor agonists or statins, might attenuate the process of EMT in peritoneal mesothelial cells. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
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 25 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis Complication
RecruitingObservational study
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Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
Not yet recruiting
Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
RecruitingObservational study
Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
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Recruiting
STarting incrEmental Prescription of Peritoneal Dialysis
Peritoneal Dialysis (PD), Kidney Failure
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.
Isaac Teitelbaum, MD principal investigator
University of Colorado, Denver
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 Peritoneal Dialysis Complication, run by University of Colorado, Denver 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 3 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 25 Feb 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?
Changes in the protein expression of EMT markers (time frame: One year or at the end of the study, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.