Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
Clinical Effectiveness and Healthcare Resource Utilization in Patients With End-Stage Renal Disease Receiving Remote Patient Monitoring-Automated Peritoneal Dialysis, Manual Peritoneal Dialysis, or Hemodialysis: A Multicenter, Prospective, Observational Real-World Study
1 other identifier
observational
750
1 country
20
Brief Summary
This is a multicenter, prospective, observational real-world study designed to evaluate clinical effectiveness, quality of life, and healthcare resource utilization in patients with end-stage renal disease (ESRD) initiating dialysis therapy in China. Participants will be grouped according to the dialysis modality selected through routine clinical practice and shared decision-making with their treating physicians: remote patient monitoring-assisted automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (PD), or maintenance hemodialysis (HD). No study-specific interventions will be assigned. The study will compare outcomes across these cohorts, including quality of life, social reintegration, clinical outcomes (e.g., complications and survival), and healthcare resource utilization. Propensity score matching will be applied to adjust for baseline differences between cohorts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2026
CompletedFirst Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
August 24, 2026
August 1, 2026
3 years
July 20, 2026
August 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient survival rates
6, 12, and 24 months
Secondary Outcomes (12)
Quality of Life Scores (EQ-5D-5L)
6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
6, 12, and 24 months
Social Reintegration
6, 12, and 24 months
Social Reintegration
6, 12 and 24 months
Social Reintegration
6, 12 and 24 months
- +7 more secondary outcomes
Other Outcomes (14)
Incidence of infection-related complications
1, 3, 6, 12, 18, and 24 months
Incidence of cardiovascular and cerebrovascular events
1, 3, 6, 12, 18, and 24 months
Incidence of dialysis access-related complications
1, 3, 6, 12, 18, and 24 months
- +11 more other outcomes
Study Arms (3)
RPM-APD cohort
Manual PD cohort
HD cohort
Interventions
RPM-APD refers to peritoneal dialysis performed at home using an APD cycler, with the prescription, treatment process, monitoring, and management conducted via a remote management system.
Manual PD refers to home-based dialysis exchange therapy performed by the patient/caregiver according to the physician's prescription without the use of automated equipment.
Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.
Eligibility Criteria
This study plans to screen Chinese patients receiving remote patient monitoring-automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (manual PD), or maintenance hemodialysis (HD). Each patient must meet all inclusion criteria and none of the exclusion criteria for this study. No exceptions are permitted under any circumstances.
You may qualify if:
- Aged ≥ 18 years and \< 80 years.
- Diagnosed with ESRD and planned to initiate RPM-APD / manual PD / HD as maintenance dialysis within 3 months after signing the ICF.
- Able to continue long-term follow-up and treatment at the study site after enrollment.
- Voluntarily sign the ICF and are able to complete study visits and questionnaires as required by the Investigator or have a caregiver to assist in completing study-related procedures.
You may not qualify if:
- Diagnosed with acute kidney injury (AKI).
- Received dialysis therapy for more than 1 month.
- History of kidney transplantation.
- Presence of other severe diseases, such as malignancies with active or residual lesions despite treatment, systemic infections, decompensated liver cirrhosis, severe lactic acidosis, etc.
- Patients with HIV infection or syphilis infection.
- Presence of psychiatric disorders or inability to cooperate.
- Pregnant or breastfeeding women, as well as women of childbearing potential unwilling to use effective contraception during the study period.
- Currently participating in another interventional study or having participated in another interventional study within 1 month prior to enrollment.
- Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, 130041, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190, China
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310007, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Global CORP Clinical Trials Disclosure
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
August 24, 2026
Study Start
June 17, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
August 24, 2026
Record last verified: 2026-08