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RECRUITING
NCT07781124

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

Sponsor: Vantive Health LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

OBSERVATIONAL

Enrollment

750

Start Date

2026-06-17

Completion Date

2029-06-30

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

Locations (20)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

The Second Norman Bethune Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China