End-Stage Kidney Disease (ESKD)NCT07769190
Cardiovascular Mortality Prediction in Maintenance Hemodialysis Patients
An observational study of End-Stage Kidney Disease (ESKD) and Cardiovascular Disease, run by Huashan Hospital at 1 site in China.
Trial summary
This prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis. During the first year after enrollment, four scheduled assessments are used to characterize demographic factors, dialysis treatment, medication use, routine laboratory… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-Stage Kidney Disease (ESKD), Cardiovascular Disease, Secondary Hyperparathyroidism (SHPT)
- What is being tested?
- One-Year Serum Phosphate Target Achievement Rate and Parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2021to 21 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months at the Hemodialysis Center of Huashan Hospital, Fudan University. Participants are selected according to the prespecified eligibility criteria and are observed under routine clinical care without a study-assigned treatment.
Who may be able to join
- Receipt of maintenance hemodialysis for at least 3 months.
- Adequate ability to understand the study and communicate with the investigators.
- Provision of written informed consent.
Who cannot join
- Age younger than 18 years or older than 85 years.
- Pregnancy or plans to become pregnant during the relevant study period.
- Participation in another clinical research study within the preceding month.
- Presence of a disease or clinical condition considered likely to materially affect serum phosphate concentrations.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Development of a Mortality Prediction Model for Patients Receiving Maintenance Hemodialysis
This prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis. During the first year after enrollment, four scheduled assessments are used to characterize demographic factors, dialysis treatment, medication use, routine laboratory measures, and the proportion of serum phosphate measurements within the protocol-defined target range. Participants are subsequently followed for cardiovascular mortality. The study evaluates factors associated with serum phosphate target achievement and develops a cardiovascular mortality prediction model in the overall cohort, with a prespecified subgroup analysis among participants who undergo parathyroidectomy. No treatment or procedure is assigned by the study investigators.
Read the detailed description
This is a prospective observational cohort study conducted at the Hemodialysis Center of Huashan Hospital, Fudan University. Adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months and meet the eligibility criteria are enrolled after providing written informed consent.
During the first year after enrollment, four scheduled assessments are performed. Data collected include demographic and clinical characteristics, dialysis treatment parameters, medication use, complete blood count, routine biochemical measurements, immunologic measurements, and other clinically relevant indicators. The principal exposure is the one-year serum phosphate target achievement rate, defined as the number of evaluable serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the one-year assessment period.
Following the one-year exposure-assessment period, participants are followed for cardiovascular mortality for up to 5 years. The primary objective is to evaluate the association between the one-year serum phosphate target achievement rate and cardiovascular mortality and to develop a cardiovascular mortality prediction model. Secondary objectives include identifying factors associated with serum phosphate target achievement and developing a mortality prediction model in the prespecified subgroup of participants who undergo parathyroidectomy as part of routine clinical care.
Descriptive analyses and appropriate parametric or nonparametric tests are used to summarize and compare participant characteristics. Multivariable regression is used to evaluate factors associated with serum phosphate target achievement. Cox proportional hazards regression and prespecified statistical or machine-learning methods are used to evaluate cardiovascular mortality risk and develop prognostic models. All statistical tests are two-sided with an alpha level of 0.05. No study-specific treatment is assigned, and clinical management is determined independently by the treating physicians.
- Conditions
- End-Stage Kidney Disease (ESKD), Cardiovascular Disease, Secondary Hyperparathyroidism (SHPT)
- Being tested
- One-Year Serum Phosphate Target Achievement Rate, Parathyroidectomy
- Keywords
- Maintenance Hemodialysis, Cardiovascular Mortality, Serum Phosphate
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Year Serum Phosphate Target Achievement RateOther
The one-year serum phosphate target achievement rate is calculated as the number of evaluable scheduled serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the first year after enrollment. Four scheduled assessments are planned. Serum phosphate management is determined by routine clinical care and is not assigned by the study investigators.
ParathyroidectomyProcedure or surgery
Parathyroidectomy received as part of routine clinical care is recorded for prespecified subgroup analysis. The decision to perform parathyroidectomy is made by the treating clinical team and is not assigned by the study investigators.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Hemodialysis Cohort | Adults receiving maintenance hemodialysis for at least 3 months at Huashan Hospital are observed without a study-assigned intervention. Demographic, clinical, medication, laboratory, and dialysis-treatment data are recorded during a one-year assessment period, followed by longitudinal ascertainment of cardiovascular mortality. Participants may be classified according to serum phosphate target achievement and parathyroidectomy status for prespecified analyses. Receives: Other: One-Year Serum Phosphate Target Achievement Rate; Procedure: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality
Occurrence and date of death attributed to cardiovascular disease during follow-up, ascertained through study follow-up and available clinical or death records.
Measured: Up to 5 years after completion of the 1-year exposure-assessment period
Secondary outcomes (2)
One-Year Serum Phosphate Target Achievement Rate
The number of evaluable scheduled serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the first year after enrollment. Four scheduled assessments are planned for each participant.
Measured: During the first year after enrollment
Mortality in the Parathyroidectomy Subgroup
Occurrence and date of death during follow-up among participants who undergo parathyroidectomy as part of routine clinical care. These data are used for prespecified subgroup prognostic modeling.
Measured: Up to 5 years after completion of the 1-year exposure-assessment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start16 Jul 2021
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769190
- Sponsor's protocol ID
- KY2021-584
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mortality Prediction Model for Patients Receiving Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07769190
- Acronym / sponsor ID
- KY2021-584
- Conditions
- End-Stage Kidney Disease (ESKD), Cardiovascular Disease, Secondary Hyperparathyroidism (SHPT)
- Keywords
- Maintenance Hemodialysis, Cardiovascular Mortality, Serum Phosphate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 17 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 prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis. During the first year after enrollment, four scheduled assessments are used to characterize demographic factors, dialysis treatment, medication use, routine laboratory measures, and the proportion of serum phosphate measurements within the protocol-defined target range. Participants are subsequently followed for cardiovascular mortality. The study evaluates factors associated with serum phosphate target achievement and develops a cardiovascular mortality prediction model in the overall cohort, with a prespecified subgroup analysis among participants who undergo parathyroidectomy. No treatment or procedure is assigned by the study investigators.
Detailed description
This is a prospective observational cohort study conducted at the Hemodialysis Center of Huashan Hospital, Fudan University. Adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months and meet the eligibility criteria are enrolled after providing written informed consent.
During the first year after enrollment, four scheduled assessments are performed. Data collected include demographic and clinical characteristics, dialysis treatment parameters, medication use, complete blood count, routine biochemical measurements, immunologic measurements, and other clinically relevant indicators. The principal exposure is the one-year serum phosphate target achievement rate, defined as the number of evaluable serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the one-year assessment period.
Following the one-year exposure-assessment period, participants are followed for cardiovascular mortality for up to 5 years. The primary objective is to evaluate the association between the one-year serum phosphate target achievement rate and cardiovascular mortality and to develop a cardiovascular mortality prediction model. Secondary objectives include identifying factors associated with serum phosphate target achievement and developing a mortality prediction model in the prespecified subgroup of participants who undergo parathyroidectomy as part of routine clinical care.
Descriptive analyses and appropriate parametric or nonparametric tests are used to summarize and compare participant characteristics. Multivariable regression is used to evaluate factors associated with serum phosphate target achievement. Cox proportional hazards regression and prespecified statistical or machine-learning methods are used to evaluate cardiovascular mortality risk and develop prognostic models. All statistical tests are two-sided with an alpha level of 0.05. No study-specific treatment is assigned, and clinical management is determined independently by the treating physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Hemodialysis Cohort | – | Other: One-Year Serum Phosphate Target Achievement Rate, Procedure: ParathyroidectomyAdults receiving maintenance hemodialysis for at least 3 months at Huashan Hospital are observed without a study-assigned intervention. Demographic, clinical, medication, laboratory, and dialysis-treatment data are recorded during a one-year assessment period, followed by longitudinal ascertainment of cardiovascular mortality. Participants may be classified according to serum phosphate target achievement and parathyroidectomy status for prespecified analyses. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months at the Hemodialysis Center of Huashan Hospital, Fudan University. Participants are selected according to the prespecified eligibility criteria and are observed under routine clinical care without a study-assigned treatment.
Key inclusion criteria (3 listed)
- Receipt of maintenance hemodialysis for at least 3 months.
- Adequate ability to understand the study and communicate with the investigators.
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- Age younger than 18 years or older than 85 years.
- Pregnancy or plans to become pregnant during the relevant study period.
- Participation in another clinical research study within the preceding month.
- Presence of a disease or clinical condition considered likely to materially affect serum phosphate concentrations.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
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 |
|---|---|---|
| One-Year Serum Phosphate Target Achievement RateThe one-year serum phosphate target achievement rate is calculated as the number of evaluable scheduled serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the first year after enrollment. Four scheduled assessments are planned. Serum phosphate management is determined by routine clinical care and is not assigned by the study investigators. | Other | Maintenance Hemodialysis Cohort |
| ParathyroidectomyParathyroidectomy received as part of routine clinical care is recorded for prespecified subgroup analysis. The decision to perform parathyroidectomy is made by the treating clinical team and is not assigned by the study investigators. | Procedure or surgery | Maintenance Hemodialysis Cohort |
Primary outcome
Cardiovascular Mortality
Time frame: Up to 5 years after completion of the 1-year exposure-assessment period
Occurrence and date of death attributed to cardiovascular disease during follow-up, ascertained through study follow-up and available clinical or death records.
2 secondary outcomes
One-Year Serum Phosphate Target Achievement Rate
Time frame: During the first year after enrollment
Mortality in the Parathyroidectomy Subgroup
Time frame: Up to 5 years after completion of the 1-year exposure-assessment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for End-Stage Kidney Disease (ESKD)
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
Not yet recruiting
Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Not yet recruiting
Virtual Reality-Guided Imagery in Hemodialysis Patients ( VRGI-HD )
End-Stage Kidney Disease (ESKD)
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. This study is not recruiting at the moment.
Jing Chen principal investigator
Huashan Hospital
1 site 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 Kidney Disease (ESKD) and Cardiovascular Disease, run by Huashan Hospital at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Mortality (time frame: Up to 5 years after completion of the 1-year exposure-assessment period). 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 17 Aug 2026.