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

August 18, 2026 updated by: Vantive Health LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
      • Beijing, Beijing Municipality, China, 100034
      • Beijing, Beijing Municipality, China, 100080
        • Not yet recruiting
        • Beijing Haidian Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Not yet recruiting
        • Hebei Medical University Third Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Not yet recruiting
        • The First Affiliated Hospital of Baotou Medical College
        • Contact:
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
    • Jilin
      • Changchun, Jilin, China, 130041
        • Not yet recruiting
        • The Second Norman Bethune Hospital of Jilin University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266555
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Yantai, Shandong, China, 264000
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300190
        • Not yet recruiting
        • Tianjin First Central Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310007
        • Not yet recruiting
        • Hangzhou Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RPM-APD cohort
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.
Manual PD cohort
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.
HD cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient survival rates
Time Frame: 6, 12, and 24 months
6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Scores (EQ-5D-5L)
Time Frame: 6, 12 and 24 months
Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales
6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
Time Frame: 6, 12, and 24 months
Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)
6, 12, and 24 months
Social Reintegration
Time Frame: 6, 12, and 24 months
Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)
6, 12, and 24 months
Social Reintegration
Time Frame: 6, 12 and 24 months
Social functioning and reintegration assessed using the EQ-5D-5L
6, 12 and 24 months
Social Reintegration
Time Frame: 6, 12 and 24 months
Social functioning and reintegration assessed using supplementary questionnaires
6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time Frame: 6, 12, and 24 months
Assessment of healthcare resource utilization including hospitalization rate
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time Frame: 6, 12, and 24 months
Assessment of healthcare resource utilization including number of hospitalizations
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time Frame: 6, 12, and 24 months
Assessment of healthcare resource utilization including length of hospital stay
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time Frame: 6, 12, and 24 months
Assessment of healthcare resource utilization including outpatient and emergency visits
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time Frame: 6, 12, and 24 months
Assessment of healthcare resource utilization including total hospitalization costs
6, 12, and 24 months
Healthcare workforce utilization
Time Frame: 6, 12, and 24 months
Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire
6, 12, and 24 months
Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)
Time Frame: 6, 12, and 24 months
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
6, 12, and 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infection-related complications
Time Frame: 1, 3, 6, 12, 18, and 24 months
Infection related complications including but not limited to peritonitis, pulmonary infections, peritoneal dialysis catheter-related infections, hemodialysis catheter-related infections, and urinary tract infections.
1, 3, 6, 12, 18, and 24 months
Incidence of cardiovascular and cerebrovascular events
Time Frame: 1, 3, 6, 12, 18, and 24 months
Cardiovascular events include but are not limited to acute myocardial infarction, angina, sudden cardiac death, heart failure, arrhythmia and other ischemic heart diseases. Cerebrovascular events include but are not limited to stroke, cerebral hemorrhage, and peripheral arterial disease.
1, 3, 6, 12, 18, and 24 months
Incidence of dialysis access-related complications
Time Frame: 1, 3, 6, 12, 18, and 24 months
dialysis access-related complications including access-related infections and dysfunction for both PD and HD: Peritoneal dialysis catheter-related infections, Peritoneal dialysis catheter dysfunction, Hemodialysis access-related infections and Hemodialysis access dysfunction
1, 3, 6, 12, 18, and 24 months
Change from baseline in 24-hour urine output
Time Frame: 3, 12, and 24 months
For PD patients, 24-hour urine volume data is collected during dialysis adequacy assessment. For HD patients, 24-hour urine volume is the average volume over two consecutive days (a dialysis day and a non-dialysis day).
3, 12, and 24 months
Dialysis quality control indicators
Time Frame: 6, 12, and 24 months
The rate of achieving the standard for small molecule solute clearance
6, 12, and 24 months
Dialysis quality control indicators
Time Frame: 6, 12, and 24 months
Hypertension control rate: The proportion of maintenance HD or PD patients meeting the blood pressure control targets during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Time Frame: 6, 12, and 24 months
Renal anemia control rate: The proportion of maintenance HD or PD patients with hemoglobin (Hb) levels ≥ 110 g/L during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Time Frame: 6, 12, and 24 months
CKD-Mineral and Bone Disorder (CKD-MBD) indicators control rate: The proportion of maintenance HD or PD patients meeting the control standards for CKD-MBD indicators during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Time Frame: 6, 12, and 24 months
Serum albumin control rate: The proportion of maintenance HD or PD patients with serum albumin levels ≥ 35 g/L during the assessment period
6, 12, and 24 months
Proportion of patients transferred to HD
Time Frame: 6, 12, and 24 months
Transferred to HD is defined as transfer from PD to HD for ≥ 30 consecutive days
6, 12, and 24 months
Ultrafiltration volume and solute clearance
Time Frame: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including 24-hour ultrafiltration volume
3, 12, and 24 months
Ultrafiltration volume and solute clearance
Time Frame: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including weekly residual renal Kt/V, weekly dialysis Kt/V, and weekly total Kt/V
3, 12, and 24 months
Ultrafiltration volume and solute clearance
Time Frame: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including weekly residual renal creatinine clearance (Ccr), weekly dialysis Ccr, and weekly total Ccr.
3, 12, and 24 months
Change from baseline in blood pressure
Time Frame: 1, 3, 6, 12, 18, and 24 months
Office blood pressure (OBP), defined as blood pressure (systolic and diastolic) measured in a healthcare setting by a physician, nurse, or other trained professional using a validated sphygmomanometer.
1, 3, 6, 12, 18, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BXU625422

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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