China Q Cohort Study

NCT04197674 | Unknown DMC

• 1 other identifier: China Q Cohort
• Study Type: observational
• Target: 903
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis; Peritoneal Dialysis; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants with major cardiovascular event composite (MACE)

  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

  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

  From the first day receiving assigned treatment to the end of 3rd year follow-up

• Healthy utility

  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

  From the first day receiving assigned treatment to the end of 3rd year follow-up

Study Arms (2)

Peritoneal dialysis group

Patients who randomized to peritoneal dialysis

Other: Dialysis modality

Hemodialysis group

Patients who randomized to conventional in-center hemodialysis

Other: Dialysis modality

Interventions

Dialysis modality 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; Peritoneal dialysis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

End stage kidney disease patients who randomly assigned to receive peritoneal dialysis and conventional in-center hemodialysis

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38899545 DERIVED

Study Officials

• Xueqing Yu

  yuxq@mail.sysu.edu.cn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqing Yu

CONTACT

86-20-87755766; yuxq@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 13, 2019
• Study Start: January 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

CN (1)