An observational study in End-Stage Kidney Disease (ESKD), Cardiovascular Disease and Secondary Hyperparathyroidism (SHPT), sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Huashan Hospital · Observational
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 192 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
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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.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: One-Year Serum Phosphate Target Achievement Rate · Procedure: Parathyroidectomy
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.
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.
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.
Time frame: Up to 5 years after completion of the 1-year exposure-assessment period
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.
Time frame: 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.
Time frame: Up to 5 years after completion of the 1-year exposure-assessment period
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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