Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
Recruiting · NCT07781124 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vantive Health LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
20 locations listed.
- 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