ClinicalTrials.gg
RecruitingNCT07781124Updated Aug 24, 2026

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

An observational study in End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), sponsored by Vantive Health LLC. Recruiting at 20 sites in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Vantive Health LLC (formerly part of Baxter Healthcare Corporation) · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Kidney Failure, Chronic by Baxter Healthcare Corporation — 1 open to participants now, 1 under way, none of them phase 3. Kidney Failure, Chronic · Baxter Healthcare Corporation.

Started
2026
the only one that year
Observational
5 of 34
1 open now
Registered
34th of 34
by date

Among the 34 studies in Kidney Failure, Chronic by Baxter Healthcare Corporation, this one is the only one that started in 2026, is one of 5 observational ones, and was the 34th registered.

Kidney Failure, Chronic

2,109 studies on the registry are indexed under Kidney Failure, Chronic; 274 are open to participants now.

Browse Kidney Failure, Chronic studies →

Open to participants now

1 of the 34 studies in Kidney Failure, Chronic by Baxter Healthcare Corporation is open now, in 1 country.

By country, each count listing its studies:

Who these studies take

Of the 169 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.

This study: 18 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Kidney Failure, Chronic by Baxter Healthcare Corporation, or all of them as a file.
02

Study 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.

03

Conditions studied

  • End Stage Renal Disease (ESRD)
  • Chronic Kidney Disease (CKD)

Keywords

  • RPM-APD
  • Manual PD
  • Maintenance HD
04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 with active or residual lesions despite treatment, systemic infections, decompensated liver cirrhosis, severe lactic acidosis, etc.
  • Patients with infection or syphilis infection.
  • Presence of psychiatric disorders or inability to cooperate.
  • Pregnant or breastfeeding women, as well as women of unwilling to use effective 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Patient registry
No

Groups and cohorts

  • RPM-APD cohort

    Device: Remote patient monitoring-automated peritoneal (RPM-APD)

  • Manual PD cohort

    Device: Manual peritoneal dialysis (PD) cohort

  • HD cohort

    Device: Maintenance hemodialysis (HD)

Interventions

  • DeviceRemote 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.

  • DeviceManual 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.

  • DeviceMaintenance 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.

06

What researchers measure

Primary outcomes

  1. Patient survival rates

    Time frame: 6, 12, and 24 months

Secondary outcomes

  1. Quality of Life Scores (EQ-5D-5L)

    Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales

    Time frame: 6, 12 and 24 months

  2. Quality of Life Scores (KDQOL-36)

    Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)

    Time frame: 6, 12, and 24 months

  3. Social Reintegration

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

    Time frame: 6, 12, and 24 months

  4. Social Reintegration

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

    Time frame: 6, 12 and 24 months

  5. Social Reintegration

    Social functioning and reintegration assessed using supplementary questionnaires

    Time frame: 6, 12 and 24 months

  6. Healthcare Resource Utilization (Direct Medical Costs)

    Assessment of healthcare resource utilization including hospitalization rate

    Time frame: 6, 12, and 24 months

  7. Healthcare Resource Utilization (Direct Medical Costs)

    Assessment of healthcare resource utilization including number of hospitalizations

    Time frame: 6, 12, and 24 months

  8. Healthcare Resource Utilization (Direct Medical Costs)

    Assessment of healthcare resource utilization including length of hospital stay

    Time frame: 6, 12, and 24 months

  9. Healthcare Resource Utilization (Direct Medical Costs)

    Assessment of healthcare resource utilization including outpatient and emergency visits

    Time frame: 6, 12, and 24 months

  10. Healthcare Resource Utilization (Direct Medical Costs)

    Assessment of healthcare resource utilization including total hospitalization costs

    Time frame: 6, 12, and 24 months

  11. Healthcare workforce utilization

    Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire

    Time frame: 6, 12, and 24 months

  12. Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)

    Costs related to non-medical expenditures and productivity loss collected via patient questionnaires

    Time frame: 6, 12, and 24 months

Other outcomes

  1. Incidence of infection-related complications

    Infection related complications including but not limited to peritonitis, pulmonary infections, peritoneal dialysis catheter-related infections, hemodialysis catheter-related infections, and urinary tract infections.

    Time frame: 1, 3, 6, 12, 18, and 24 months

  2. Incidence of cardiovascular and cerebrovascular events

    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.

    Time frame: 1, 3, 6, 12, 18, and 24 months

  3. Incidence of dialysis access-related complications

    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

    Time frame: 1, 3, 6, 12, 18, and 24 months

  4. Change from baseline in 24-hour urine output

    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).

    Time frame: 3, 12, and 24 months

  5. Dialysis quality control indicators

    The rate of achieving the standard for small molecule solute clearance

    Time frame: 6, 12, and 24 months

  6. Dialysis quality control indicators

    Hypertension control rate: The proportion of maintenance HD or PD patients meeting the blood pressure control targets during the assessment period

    Time frame: 6, 12, and 24 months

  7. Dialysis quality control indicators

    Renal anemia control rate: The proportion of maintenance HD or PD patients with hemoglobin (Hb) levels ≥ 110 g/L during the assessment period

    Time frame: 6, 12, and 24 months

  8. Dialysis quality control indicators

    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

    Time frame: 6, 12, and 24 months

  9. Dialysis quality control indicators

    Serum albumin control rate: The proportion of maintenance HD or PD patients with serum albumin levels ≥ 35 g/L during the assessment period

    Time frame: 6, 12, and 24 months

  10. Proportion of patients transferred to HD

    Transferred to HD is defined as transfer from PD to HD for ≥ 30 consecutive days

    Time frame: 6, 12, and 24 months

  11. Ultrafiltration volume and solute clearance

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

    Time frame: 3, 12, and 24 months

  12. Ultrafiltration volume and solute clearance

    Collection of data from dialysis adequacy assessment including weekly residual renal Kt/V, weekly dialysis Kt/V, and weekly total Kt/V

    Time frame: 3, 12, and 24 months

  13. Ultrafiltration volume and solute clearance

    Collection of data from dialysis adequacy assessment including weekly residual renal creatinine clearance (Ccr), weekly dialysis Ccr, and weekly total Ccr.

    Time frame: 3, 12, and 24 months

  14. Change from baseline in blood pressure

    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.

    Time frame: 1, 3, 6, 12, 18, and 24 months

07

Study locations

1 of 20 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.

Of 150 observational studies under Kidney Failure, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Aug 24, 2026
StartActual
Jun 17, 2026
Primary completionEst.
Jun 30, 2029
CompletionEst.
Jun 30, 2029
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07781124
Lead sponsor
Vantive Health LLC
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Jun 17, 2026
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Aug 24, 2026

Study contacts

Global CORP Clinical Trials Disclosure
Contact
Global.CORP.ClinicalTrialsDisclosure@vantive.com
+1 2249484283

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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