End Stage Renal Disease on DialysisNCT04197674
China Q Cohort Study
An observational study of End Stage Renal Disease on Dialysis and Peritoneal Dialysis, run by Sun Yat-sen University at 1 site in China.
Trial summary
The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Peritoneal Dialysis, Hemodialysis
- What is being tested?
- Dialysis modality
- How many people
- 903 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 31 Dec 2021
- 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: End stage kidney disease patients who randomly assigned to receive peritoneal dialysis and conventional in-center hemodialysis
Who may be able to join
- Adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous China Q study and who enrolled in SURinD study with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks.
- Will and able to provide the informed consent form (ICF).
Who cannot join
- Patients have stopped dialysis due to kidney function recovery or kidney transplantation.
- Patients refuse to provide consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
xueqing Yu, yuxq@mail.sysu.edu.cn
About this study
Official title: China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial
The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies.
The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.
- Being tested
- Dialysis modality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis modalityOther
This is a observational cohort study, and there is no intervention for all participants. Our aim is to evaluate dialysis modality (PD and HD) on patient survival
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis group | Patients who randomized to peritoneal dialysis Receives: Other: Dialysis modality | |
| Hemodialysis group | Patients who randomized to conventional in-center hemodialysis Receives: Other: Dialysis modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants died due to any cause
Patients died due to any cause
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary outcomes (10)
Number of Participants with major cardiovascular event composite (MACE)
MACE defined as defined as the first occurrence of myocardial infarction, ischemic stroke or death from cardiovascular causes
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Number of Participants with composite outcome of MACE and all-cause death
Patients experience cardiovascular events and death.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Number of Participants with hospitalized myocardial infarction, stroke and heart failure
Patients were hospitalized due to myocardial infarction, stroke and heart failure.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Healthy utility
Healthy utility was assessed by Kidney Disease Quality of Life-Short Form (KDQoL-SF™, version 1.3) questionnaire domain of General health, with a range of 1 to 100 and higher value indicates better healthy utility
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Rate of difference in dialysis cost between PD and HD
Dialysis cost is evaluated by budget impact model which is developed by Baxter Healthcare Corporation and is a excel based calculator with higher value indicates higher cost
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of activity of daily living
Activity of daily living assessed using Activrty Daily Living (ADL) scale, with a range of 14 to 56 and a score < 14 indicates independent daily living and a higher score indicates serious dependent daily living.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of residual renal function
Residual renal function was evaluated using 24h urine volume and the unit is ml.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of hemoglobin
The unit of hemoglobin is g/L.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of serum phosphors
The unit of serum phosphors is mmol/L.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of serum albumin
The unit of serum albumin is g/L.
Measured: From the first day receiving assigned treatment to the end of 3rd year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start21 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 903 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, Principal investigator, yuxq@mail.sysu.edu.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197674
- Sponsor's protocol ID
- China Q Cohort
- Status last verified
- Sep 2021
- First submitted
- 29 Nov 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data share plan will decided before submit manuscript to journal.
Publications
Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
PubMed 38899545
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial
- ClinicalTrials.gov ID
- NCT04197674
- Acronym / sponsor ID
- China Q Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 903 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Dec 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.
The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies.
The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis group | – | Other: Dialysis modalityPatients who randomized to peritoneal dialysis |
| Hemodialysis group | – | Other: Dialysis modalityPatients who randomized to conventional in-center hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End stage kidney disease patients who randomly assigned to receive peritoneal dialysis and conventional in-center hemodialysis
Key inclusion criteria (2 listed)
- Adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous China Q study and who enrolled in SURinD study with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks.
- Will and able to provide the informed consent form (ICF).
Key exclusion criteria (2 listed)
- Patients have stopped dialysis due to kidney function recovery or kidney transplantation.
- Patients refuse to provide consent.
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 |
|---|---|---|
| Dialysis modalityThis is a observational cohort study, and there is no intervention for all participants. Our aim is to evaluate dialysis modality (PD and HD) on patient survival | Other | Hemodialysis group, Peritoneal dialysis group |
Primary outcome
Number of Participants died due to any cause
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Patients died due to any cause
10 secondary outcomes
Number of Participants with major cardiovascular event composite (MACE)
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Number of Participants with composite outcome of MACE and all-cause death
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Number of Participants with hospitalized myocardial infarction, stroke and heart failure
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Healthy utility
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Rate of difference in dialysis cost between PD and HD
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of activity of daily living
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of residual renal function
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of hemoglobin
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of serum phosphors
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Changes of serum albumin
Time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 38899545Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
- Individual participant dataSharing planned: Undecided. Data share plan will decided before submit manuscript to journal.
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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.
Xueqing Yu principal investigator
yuxq@mail.sysu.edu.cn
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 Renal Disease on Dialysis and Peritoneal Dialysis, run by Sun Yat-sen University at 1 site in China.
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 2 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 23 Sep 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 China. 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?
Contact Xueqing Yu (86-20-87755766 ext. 8174, yuxq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants died due to any cause (time frame: From the first day receiving assigned treatment to the end of 3rd year follow-up). 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 NCT04197674, 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 23 Sep 2021.