China Q Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

903 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

NCT02378350

End Stage Renal Disease

COMPLETED PHASE4

Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China

NCT01413074

End Stage Renal Disease

TERMINATED PHASE4

Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population

NCT01587443

Stage 5 Chronic Kidney Disease Hemodialysis Peritoneal Dialysis

UNKNOWN

High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

NCT03456232

Chronic Kidney Failure

UNKNOWN NA

The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis

NCT03754361

ESRD

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease on Dialysis Peritoneal Dialysis Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Peritoneal dialysis group

Patients who randomized to peritoneal dialysis

Dialysis modality

Intervention Type OTHER

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

Hemodialysis group

Patients who randomized to conventional in-center hemodialysis

Dialysis modality

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dialysis modality

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).