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CompletedNCT03261154Updated Aug 24, 2017

Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population

An observational study in End Stage Renal Disease, sponsored by Wenhu Liu. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Wenhu Liu · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,000
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 114 studies in Kidney Failure, Chronic with a site in China — 28 open to participants now, 36 under way, 1 of them phase 3. Kidney Failure, Chronic · China.

Enrollment
6th of 31
1,000 · median 250
Started
2012
with 4 others
Observational
31 of 114
11 open now
Registered
43rd of 114
by date

Among the 114 studies in Kidney Failure, Chronic with a site in China, this one is the 6th largest by enrollment of the 31 observational ones, is one of 5 that started in 2012, is one of 31 observational ones, and was the 43rd registered.

By phase

114 studies; the count open now beside each. This study's row is marked.

No phase40 · 9 open
Observationalthis study31 · 11 open
Phase 418 · 3 open
Phase 16 · 2 open
Phase 36 · 0 open
Phase 1/25 · 2 open
Phase 25 · 0 open
Phase 2/33 · 1 open

By the year they started

First in 1996; this study’s year is marked. 5 started in 2012.

Size and results

Median enrollment 150 across the 83 interventional studies, 250 across the 31 observational. Of the 55 that completed or were terminated, 7 (13%) have results posted.

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02

Study summary

Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously increasing with population aging progressing. Mineral and bone disorder (MBD) is a common complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in hemodialysis patients, as well as mortality.

Joint effects of Kidney failure and aging on elderly hemodialysis patients make the contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients. Since not much studies had been done for this specific subject, thus, research on elderly patients who is taking Maintenance hemodialysis is very necessary. This study is a retrospective research to identify optimized target value of Calcium and Phosphorus for elderly patients taking maintenance hemodialysis and hence provide guidance for clinical practices. The data for this study will be provided by Beijing Blood Purification Quality Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices will be collected amongst elderly patients who were elder than 65 years and was taking maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for hemodialysis treatment

03

Conditions studied

  • End Stage Renal Disease

Keywords

  • Serum iPTH
  • Calcium
  • Phosphate
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the data for this study will be provided by Beijing Blood Purification Quality Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices will be collected amongst elderly patients who were elder than 65 years and was taking maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016.

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

  • The data shall include the information of elderly hemodialysis patients who were 65 years or elder between Jan 1st, 2012 and Dec 31st, 2016

Exclusion criteria

Exclusion Criteria:

  • The patients who only has less than 6 months history of hemodialysis since selected in the research patient group The patients who passed away within 3 months since selected in the research patient group The patients who took less than 3 hemodialysis in a week The patients who took kidney transplant during the research time period The patients who do not have blood biochemical results in the records
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. All-cause mortality

    all patients died in our observation period

    Time frame: 5 years

Secondary outcomes

  1. CVD-related mortality

    the cause of death was cardiovascular disease related

    Time frame: 5 years

07

Study locations

1 site
  • Beijing Friendship hospital
    Beijing, Beijing 100050, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2012 to primary completion in Dec 2016, 59 months.

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

Registered
Aug 23, 2017
First posted
Aug 24, 2017
StartActual
Jan 1, 2012
Primary completionActual
Dec 31, 2016
CompletionActual
Dec 31, 2016
Last update
Aug 24, 2017
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, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03261154
Lead sponsor
Wenhu Liu
Responsible party
Wenhu Liu (Director of Nephrology Deptartment, Beijing FH, Beijing Friendship Hospital) — Sponsor-investigator
First posted
Aug 24, 2017
Start date
Jan 1, 2012
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Aug 24, 2017

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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