China Q Cohort Study

Hemodialysis Clinical Trial

Official title:

China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197674
• Other study ID #: China Q Cohort
• Status: Recruiting
• Start date: January 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: Xueqing Yu
• Phone: 86-20-87755766
• Email: yuxq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 903
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Hemodialysis
• Kidney Failure, Chronic
• Peritoneal Dialysis

Intervention

Other:
• 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

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants died due to any cause	Patients died due to any cause	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	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	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Number of Participants with composite outcome of MACE and all-cause death	Patients experience cardiovascular events and death.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Number of Participants with hospitalized myocardial infarction, stroke and heart failure	Patients were hospitalized due to myocardial infarction, stroke and heart failure.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	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	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	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	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	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.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Changes of residual renal function	Residual renal function was evaluated using 24h urine volume and the unit is ml.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Changes of hemoglobin	The unit of hemoglobin is g/L.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Changes of serum phosphors	The unit of serum phosphors is mmol/L.	From the first day receiving assigned treatment to the end of 3rd year follow-up
Secondary	Changes of serum albumin	The unit of serum albumin is g/L.	From the first day receiving assigned treatment to the end of 3rd year follow-up