End Stage Renal Disease (ESRD)NCT07781124
Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
An observational study of End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), run by Vantive Health LLC at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
- What is being tested?
- Remote patient monitoring-automated peritoneal (RPM-APD), Manual peritoneal dialysis (PD) cohort and Maintenance hemodialysis (HD)
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 20 sitesChina
- Study dates
- 17 Jun 2026to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Global CORP Clinical Trials Disclosure contact
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010
Lei Nan, nanlei566@163.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Wenge Li, wenge_lee2002@126.com
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jie Dong, jie.dong@bjmu.edu.cn
- Not yet recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080
Gang Fu, fugang126@126.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wen Tang, tangwen@126.com
- Not yet recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, 130041
Wenpeng Cui, wenpengcui@163.com
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Hao Zhang, Zhanghaoliaoqing@163.com
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Xiaohui Liao, 1263201771@qq.com
- Not yet recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Xusheng Liu, liuxu801@126.com
- Not yet recruiting
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310007
Mengli Tong, 1994185637@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Xuanyi Du, dxy_shennei@126.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
Guangqun Xing, gqx99monash@163.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Niansong Wang, wangniansong2012@163.com
- Not yet recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Yanqing Chi, lilychi@sina.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190
Wenxiu Chang, changwx@sina.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Huiming Wang, 736238012@qq.com
- Not yet recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Liang Wang, wangliang_wuxi@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jing Lv, drlvjing@163.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Peng Li, yhdgcplipeng@163.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Fengmin Shao, fengminshao@126.com
About this study
Official 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
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.
- Being tested
- Remote patient monitoring-automated peritoneal (RPM-APD), Manual peritoneal dialysis (PD) cohort, Maintenance hemodialysis (HD)
- Keywords
- RPM-APD, Manual PD, Maintenance HD
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) cohortDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RPM-APD cohort | Not described Receives: Device: Remote patient monitoring-automated peritoneal (RPM-APD) | |
| Manual PD cohort | Not described Receives: Device: Manual peritoneal dialysis (PD) cohort | |
| HD cohort | Not described Receives: Device: Maintenance hemodialysis (HD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival rates
Measured: 6, 12, and 24 months
Secondary outcomes (12)
Quality of Life Scores (EQ-5D-5L)
Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales
Measured: 6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)
Measured: 6, 12, and 24 months
Social Reintegration
Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)
Measured: 6, 12, and 24 months
Social Reintegration
Social functioning and reintegration assessed using the EQ-5D-5L
Measured: 6, 12 and 24 months
Social Reintegration
Social functioning and reintegration assessed using supplementary questionnaires
Measured: 6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including hospitalization rate
Measured: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including number of hospitalizations
Measured: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including length of hospital stay
Measured: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including outpatient and emergency visits
Measured: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including total hospitalization costs
Measured: 6, 12, and 24 months
Healthcare workforce utilization
Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire
Measured: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start17 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781124
- Sponsor's protocol ID
- BXU625422
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07781124
- Acronym / sponsor ID
- BXU625422
- Keywords
- RPM-APD, Manual PD, Maintenance HD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | RPM-APD cohort |
| Manual peritoneal dialysis (PD) cohortManual 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. | Device | Manual PD cohort |
| 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. | Device | HD cohort |
Primary outcome
Patient survival rates
Time frame: 6, 12, and 24 months
12 secondary outcomes
Quality of Life Scores (EQ-5D-5L)
Time frame: 6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
Time frame: 6, 12, and 24 months
Social Reintegration
Time frame: 6, 12, and 24 months
Social Reintegration
Time frame: 6, 12 and 24 months
Social Reintegration
Time frame: 6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Time frame: 6, 12, and 24 months
Healthcare workforce utilization
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)
Time frame: 6, 12, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
Related trials for End Stage Renal Disease (ESRD)
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global CORP Clinical Trials Disclosure contact
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), run by Vantive Health LLC at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Global CORP Clinical Trials Disclosure (+1 2249484283, Global.CORP.ClinicalTrialsDisclosure@vantive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival rates (time frame: 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.