Clinical trial NCT04197674: China Q Cohort Study
Official title: China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease on Dialysis
Peritoneal Dialysis
Hemodialysis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 903
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: End stage kidney disease patients who randomly assigned to receive peritoneal dialysis and conventional in-center hemodialysis

Brief 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) 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.


Eligibility criteria: 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).

Exclusion Criteria:

* Patients have stopped dialysis due to kidney function recovery or kidney transplantation.
* Patients refuse to provide consent.

Primary outcomes:
measure: Number of Participants died due to any cause
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary outcomes:
measure: Number of Participants with major cardiovascular event composite (MACE)
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Number of Participants with composite outcome of MACE and all-cause death
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Number of Participants with hospitalized myocardial infarction, stroke and heart failure
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Healthy utility
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Rate of difference in dialysis cost between PD and HD
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Changes of activity of daily living
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Changes of residual renal function
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Changes of hemoglobin
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Changes of serum phosphors
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
measure: Changes of serum albumin
timeFrame: From the first day receiving assigned treatment to the end of 3rd year follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: yuxq@mail.sysu.edu.cn
name: Xueqing Yu
role: PRINCIPAL_INVESTIGATOR
References: