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

18. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

750

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
      • Beijing, Beijing Municipality, Kina, 100034
        • Har ikke rekruttert ennå
        • Peking University First Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina, 100080
        • Har ikke rekruttert ennå
        • Beijing Haidian Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina, 100191
        • Har ikke rekruttert ennå
        • Peking University Third Hospital
        • Ta kontakt med:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400010
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Chongqing Medical University
        • Ta kontakt med:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Har ikke rekruttert ennå
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Ta kontakt med:
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050051
        • Har ikke rekruttert ennå
        • Hebei Medical University Third Hospital
        • Ta kontakt med:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150001
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Harbin Medical University
        • Ta kontakt med:
    • Henan
      • Zhengzhou, Henan, Kina, 450003
        • Har ikke rekruttert ennå
        • Henan Provincial People's Hospital
        • Ta kontakt med:
    • Hubei
      • Wuhan, Hubei, Kina, 430071
        • Har ikke rekruttert ennå
        • Zhongnan Hospital of Wuhan University
        • Ta kontakt med:
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Har ikke rekruttert ennå
        • The Third XIANGYA Hospital of Central South University
        • Ta kontakt med:
    • Inner Mongolia
      • Baotou, Inner Mongolia, Kina, 014010
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Baotou Medical College
        • Ta kontakt med:
    • Jiangsu
      • Wuxi, Jiangsu, Kina, 214023
    • Jilin
      • Changchun, Jilin, Kina, 130041
        • Har ikke rekruttert ennå
        • The Second Norman Bethune Hospital of Jilin University
        • Ta kontakt med:
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Ta kontakt med:
    • Shandong
      • Qingdao, Shandong, Kina, 266555
        • Har ikke rekruttert ennå
        • The Affiliated Hospital of Qingdao University
        • Ta kontakt med:
      • Yantai, Shandong, Kina, 264000
        • Har ikke rekruttert ennå
        • Yantai YuHuangDing Hospital
        • Ta kontakt med:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200233
        • Har ikke rekruttert ennå
        • Shanghai Sixth People's Hospital
        • Ta kontakt med:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300190
        • Har ikke rekruttert ennå
        • Tianjin First Central Hospital
        • Ta kontakt med:
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310007
        • Har ikke rekruttert ennå
        • Hangzhou Hospital of Traditional Chinese Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
RPM-APD cohort
Enhet: 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
Enhet: 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
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Patient survival rates
Tidsramme: 6, 12, and 24 months
6, 12, and 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Life Scores (EQ-5D-5L)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6, 12 and 24 months
Social functioning and reintegration assessed using the EQ-5D-5L
6, 12 and 24 months
Social Reintegration
Tidsramme: 6, 12 and 24 months
Social functioning and reintegration assessed using supplementary questionnaires
6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Tidsramme: 6, 12, and 24 months
Assessment of healthcare resource utilization including hospitalization rate
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6, 12, and 24 months
Assessment of healthcare resource utilization including total hospitalization costs
6, 12, and 24 months
Healthcare workforce utilization
Tidsramme: 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)
Tidsramme: 6, 12, and 24 months
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
6, 12, and 24 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of infection-related complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vantive Health LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. juni 2026

Primær fullføring (Antatt)

30. juni 2029

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

18. august 2026

Først lagt ut (Faktiske)

24. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BXU625422

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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