Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities

NCT07781124 · tracked via the Priya Life Science China tracker

Sponsor

Vantive Health LLC

Phase

Observational

Started

2026-06-17

Last updated

2026-08-24

Condition(s) studied

End Stage Renal Disease (ESRD)Chronic Kidney Disease (CKD)

Investigational drug(s) / intervention(s)

Remote patient monitoring-automated peritoneal (RPM-APD)Manual peritoneal dialysis (PD) cohortMaintenance hemodialysis (HD)

Remote patient monitoring-automated peritoneal (RPM-APD): 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 peritoneal dialysis (PD) cohort: 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 hemodialysis (HD): Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

79 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Patient survival rates — 6, 12, and 24 months

Trial sites (20)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality	Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
Beijing Haidian Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
Peking University Third Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Not Yet Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	Not Yet Recruiting
Hebei Medical University Third Hospital	Shijiazhuang	Hebei	Not Yet Recruiting
The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	Not Yet Recruiting
Henan Provincial People's Hospital	Zhengzhou	Henan	Not Yet Recruiting
Zhongnan Hospital of Wuhan University	Wuhan	Hubei	Not Yet Recruiting
The Third Xiangya Hospital of Central South University	Changsha	Hunan	Not Yet Recruiting
The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia	Not Yet Recruiting
Wuxi People's Hospital	Wuxi	Jiangsu	Not Yet Recruiting
The Second Norman Bethune Hospital of Jilin University	Changchun	Jilin	Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	Not Yet Recruiting
The Affiliated Hospital of Qingdao University	Qingdao	Shandong	Not Yet Recruiting
Yantai Yuhuangding Hospital	Yantai	Shandong	Not Yet Recruiting
Shanghai Sixth People's Hospital	Shanghai	Shanghai Municipality	Not Yet Recruiting
Tianjin First Central Hospital	Tianjin	Tianjin Municipality	Not Yet Recruiting
Hangzhou Hospital of Traditional Chinese Medicine	Hangzhou	Zhejiang	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07781124 on ClinicalTrials.gov ↗ ← All trials in China