Peritoneal DialysisNCT04076930
Effects of Renin-Angiotensin System Inhibitors in Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Among antihypertensive medications, RAS inhibitor classes, namely angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) have the most prospective data on mortality and cardiovascular outcomes in specific high-risk populations with mild to moderate chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)
- How many people
- 1,468 participants
- Where
- 1 siteThailand
- Study dates
- 31 Aug 2019to Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ESKD patients undergoing PD from January 1, 2006, to December 31, 2017, and followed to December 2018.
Who may be able to join
- Adult patients aged 18 years or over at the date of PD initiation
- Patients with ESKD who were undergoing PD either continuous ambulatory peritoneal dialysis or automated peritoneal dialysis between January 1, 2006, to December 31, 2017
- Received PD treatment more than 90 days in an outpatient nephrology clinic visit after the date of PD initiation
- Received of any outpatient prescriptions within 90 days after the date of PD initiation
Who cannot join
- Previously been treated by maintenance hemodialysis (for more than 90 days) or initiated PD for acute kidney injury or after a failed kidney transplantation
- Died within 90 days after the date of PD initiation
- Received a combination of ACEIs and ARBs therapy
- Received ACEIs/ARBs within 180 days before PD initiation
- Had no information regarding ACEI/ARB dosage regimen during the follow-up period
- Inadequate follow-up clinical information on blood pressure monitoring
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: Effects of Renin-Angiotensin System Inhibitors on Mortality and Cardiovascular Outcomes in Peritoneal Dialysis Patients: A Retrospective Cohort Study in Thailand
Among antihypertensive medications, RAS inhibitor classes, namely angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) have the most prospective data on mortality and cardiovascular outcomes in specific high-risk populations with mild to moderate chronic kidney disease (CKD). Whereas, long-term data on the risks and benefits of ACEI/ARB usage in end-stage kidney disease (ESKD) patients undergoing peritoneal dialysis (PD) are limited. Recently, increasing clinical studies suggested that ACEI/ARB had a beneficial effect on intermediate outcomes, including short-term blood pressure variability, left ventricular hypertrophy, and may have an important role in the peritoneum and the kidney protection. Subsequently, treatment with ACEI/ARB has been recommended by the International Society for Peritoneal Dialysis for PD patients with significant residual kidney function (RKF).
Although existing reviews demonstrated that ACEI/ARB significantly has benefit in preserving RKF in PD patients, evidence regarding the relative efficacy on mortality, cardiovascular outcomes, and adverse events is lacking. Given that there exist few controlled trials of the effectiveness of ACEI/ARB in PD patients, we intend to perform a retrospective cohort study to assess the association between the use of ACEI/ARB and the risk of long-term mortality, cardiovascular outcomes, and adverse events in terms of hyperkalemia.
Read more
A retrospective cohort of Thai PD patients will be constructed by using the local joint registry data of adult PD patients from five centers in Thailand between 2006 to 2017 and followed to December 2018. We will link the following health datasets: (i) the electronic health records, contains outpatient and inpatient data; (ii) the Support System Pharmacy Dispensing extract, an administrative database which covers pharmacy dispensing; (iii) the PD Patient Care Database, which provides patient-level detail on sociodemographic and clinical characteristics as well as long-term PD care data; and (iv) the Laboratory Support System extract, which includes claims and routine laboratory results.
The exposure of interest in this cohort will be the use of ACEI/ARB within a 90-day after the date of PD initiation. Outcomes of interest will include all-cause mortality, cardiovascular mortality, a composite endpoint of cardiovascular events, and adverse events in terms of hyperkalemia.
- Conditions
- Peritoneal Dialysis
- Being tested
- angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)
- Keywords
- Cardiovascular, Hyperkalemia, Mortality, Peritoneal dialysis, Renin-angiotensin system, Retrospective cohort
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)Drug
The use of ACEI/ARB within a 90-day after the date of PD initiation (exposure ascertainment window period).
| Study group | Role | What they receive |
|---|---|---|
| ACEI/ARB users | Not described Receives: Drug: angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) | |
| ACEI/ARB non-users | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 12 years
Cardiovascular mortality
Measured: 12 years
Secondary outcomes (2)
Composite endpoint of atherosclerotic cardiovascular disease (ASCVD) events
ASCVD events of interest will include hospitalization for acute fatal and nonfatal myocardial infarction, coronary or other arterial revascularization, fatal and nonfatal stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.
Measured: 12 years
Hyperkalemia
Incident hyperkalemia will define as a serum potassium concentration of more than 5.0 mEq/L. The severity of hyperkalemia will be categorized as mild (>5.0 to <5.5 mEq/L), moderate (5.5 to 6.0 mEq/L), and severe (>6.0 mEq/L).
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start31 Aug 2019
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chidchanok Ruengorn, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076930
- Sponsor's protocol ID
- THOR-PD: RAS Inhibitors
- Status last verified
- Nov 2019
- First submitted
- 30 Aug 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data from the retrospective cohort study part will be made available at the end of the study, on request. Requests will subject to approval by the chief investigator, the advisory Committee and the relevant ethical bodies.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Renin-Angiotensin System Inhibitors on Mortality and Cardiovascular Outcomes in Peritoneal Dialysis Patients: A Retrospective Cohort Study in Thailand
- ClinicalTrials.gov ID
- NCT04076930
- Acronym / sponsor ID
- THOR-PD: RAS Inhibitors
- Conditions
- Peritoneal Dialysis
- Keywords
- Cardiovascular, Hyperkalemia, Mortality, Peritoneal dialysis, Renin-angiotensin system, Retrospective cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,468 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 4 Sep 2019 (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.
Among antihypertensive medications, RAS inhibitor classes, namely angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) have the most prospective data on mortality and cardiovascular outcomes in specific high-risk populations with mild to moderate chronic kidney disease (CKD). Whereas, long-term data on the risks and benefits of ACEI/ARB usage in end-stage kidney disease (ESKD) patients undergoing peritoneal dialysis (PD) are limited. Recently, increasing clinical studies suggested that ACEI/ARB had a beneficial effect on intermediate outcomes, including short-term blood pressure variability, left ventricular hypertrophy, and may have an important role in the peritoneum and the kidney protection. Subsequently, treatment with ACEI/ARB has been recommended by the International Society for Peritoneal Dialysis for PD patients with significant residual kidney function (RKF).
Although existing reviews demonstrated that ACEI/ARB significantly has benefit in preserving RKF in PD patients, evidence regarding the relative efficacy on mortality, cardiovascular outcomes, and adverse events is lacking. Given that there exist few controlled trials of the effectiveness of ACEI/ARB in PD patients, we intend to perform a retrospective cohort study to assess the association between the use of ACEI/ARB and the risk of long-term mortality, cardiovascular outcomes, and adverse events in terms of hyperkalemia.
A retrospective cohort of Thai PD patients will be constructed by using the local joint registry data of adult PD patients from five centers in Thailand between 2006 to 2017 and followed to December 2018. We will link the following health datasets: (i) the electronic health records, contains outpatient and inpatient data; (ii) the Support System Pharmacy Dispensing extract, an administrative database which covers pharmacy dispensing; (iii) the PD Patient Care Database, which provides patient-level detail on sociodemographic and clinical characteristics as well as long-term PD care data; and (iv) the Laboratory Support System extract, which includes claims and routine laboratory results.
The exposure of interest in this cohort will be the use of ACEI/ARB within a 90-day after the date of PD initiation. Outcomes of interest will include all-cause mortality, cardiovascular mortality, a composite endpoint of cardiovascular events, and adverse events in terms of hyperkalemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI/ARB users | – | Drug: angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) |
| ACEI/ARB non-users | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ESKD patients undergoing PD from January 1, 2006, to December 31, 2017, and followed to December 2018.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or over at the date of PD initiation
- Patients with ESKD who were undergoing PD either continuous ambulatory peritoneal dialysis or automated peritoneal dialysis between January 1, 2006, to December 31, 2017
- Received PD treatment more than 90 days in an outpatient nephrology clinic visit after the date of PD initiation
- Received of any outpatient prescriptions within 90 days after the date of PD initiation
Key exclusion criteria (6 listed)
- Previously been treated by maintenance hemodialysis (for more than 90 days) or initiated PD for acute kidney injury or after a failed kidney transplantation
- Died within 90 days after the date of PD initiation
- Received a combination of ACEIs and ARBs therapy
- Received ACEIs/ARBs within 180 days before PD initiation
- Had no information regarding ACEI/ARB dosage regimen during the follow-up period
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 |
|---|---|---|
| angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)The use of ACEI/ARB within a 90-day after the date of PD initiation (exposure ascertainment window period). | Drug | ACEI/ARB users |
Primary outcome
All-cause mortality
Time frame: 12 years
Cardiovascular mortality
Time frame: 12 years
2 secondary outcomes
Composite endpoint of atherosclerotic cardiovascular disease (ASCVD) events
Time frame: 12 years
Hyperkalemia
Time frame: 12 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Undecided. Data from the retrospective cohort study part will be made available at the end of the study, on request. Requests will subject to approval by the chief investigator, the advisory Committee and the relevant ethical bodies.
Related trials for Peritoneal Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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 Peritoneal Dialysis, run by Chiang Mai University at 1 site in Thailand.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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 Thailand. 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?
Results are not available in the source record.
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?
All-cause mortality (time frame: 12 years). 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?
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 5 Nov 2019.