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NCT Number: NCT07781124

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

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.

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Chronic Kidney Disease (CKD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Haidian Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote patient monitoring-automated peritoneal (RPM-APD)

Device

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

Device

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)

Device

Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.

Primary outcomes

  1. Patient survival rates

    Time frame: 6, 12, and 24 months

Secondary outcomes

  1. 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

  2. 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)

  3. Social Reintegration

    Time frame: 6, 12, and 24 months

    Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)

  4. Social Reintegration

    Time frame: 6, 12 and 24 months

    Social functioning and reintegration assessed using the EQ-5D-5L

  5. Social Reintegration

    Time frame: 6, 12 and 24 months

    Social functioning and reintegration assessed using supplementary questionnaires

  6. Healthcare Resource Utilization (Direct Medical Costs)

    Time frame: 6, 12, and 24 months

    Assessment of healthcare resource utilization including hospitalization rate

  7. Healthcare Resource Utilization (Direct Medical Costs)

    Time frame: 6, 12, and 24 months

    Assessment of healthcare resource utilization including number of hospitalizations

  8. Healthcare Resource Utilization (Direct Medical Costs)

    Time frame: 6, 12, and 24 months

    Assessment of healthcare resource utilization including length of hospital stay

  9. Healthcare Resource Utilization (Direct Medical Costs)

    Time frame: 6, 12, and 24 months

    Assessment of healthcare resource utilization including outpatient and emergency visits

  10. Healthcare Resource Utilization (Direct Medical Costs)

    Time frame: 6, 12, and 24 months

    Assessment of healthcare resource utilization including total hospitalization costs

  11. 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

  12. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. Dialysis quality control indicators

    Time frame: 6, 12, and 24 months

    The rate of achieving the standard for small molecule solute clearance

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Ultrafiltration volume and solute clearance

    Time frame: 3, 12, and 24 months

    Collection of data from dialysis adequacy assessment including 24-hour ultrafiltration volume

  12. 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

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Global CORP Clinical Trials Disclosure

CONTACT

[email protected]

+1 2249484283

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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