CClinicalTrials.gg
Status unknownNCT04088526SURVIVORUpdated Sep 20, 2019

Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors

An interventional study of intervention group in End Stage Renal Disease on Dialysis, sponsored by Shanghai Changzheng Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jan 2016, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Not applicable
Sex
All
01

Study summary

In patients with non-dialysis-dependent end stage kidney disease (ESKD) the common transition of care to renal replacement therapy is dialysis. Each year over 70 000 Chinese transition from non-dialysis-dependent ESKD to dialysis. Whereas dialysis therapy is intended to be life-sustaining, ESKD patients have a 10-fold or higher risk of death compared with the general population. Mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. Hence, there is an urgent need to examine the emerging field of Transition of Care in ESKD. We suggest the term "peridialysis period" for this transition period for ESKD patients, so that the transition of care from non-dialysis-dependent ESKD to dialysis ESKD can be more pragmatically defined and studied. In the current study, we will investigate the mortality and its risk factors of ESKD patients during peridialysis period, and improve the survival rate and quality of life of peridialysis ESKD patients by intervening the risk factors.

02

Conditions studied

  • End Stage Renal Disease on Dialysis
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who have been diagnosed with end stage kidney disease (eGFR\<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in Yangzhou, China since January 1, 2016

Exclusion criteria

Exclusion Criteria:

  • Patients who have had a history of dialysis and have been transferred to Yangzhou during this period;
  • patients who are transferred to a dialysis area outside Yangzhou City
  • Patients who give up dialysis treatment
  • patient whose renal function recover and stop dialysis treatment;
  • Patient who receive kidney transplantation
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • Experimental
    intervention group

    Through the effective intervention of risk factors for death in patients with dialysis, the effect of mortality of peri-dialysis patients was observed.

    Combination Product: intervention group

Interventions

  • Combination productintervention group

    Through effective intervention combined with drugs and dietary guidance within 3 to 6 months, all the observation markers including blood pressure and laboratory results will reach the target target value.

06

What researchers measure

Primary outcomes

  1. mortality

    mortality and death cause

    Time frame: one year

Secondary outcomes

  1. hospitalization

    hospitalization rate and cause

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Department of Nephrology, Shanghai Changzheng Hospital
    Shanghai, Shanghai 200003, China
    • Changlin Mei, MD · Contact · chlmei1954@126.com · +862181885391
    • Xiaojing Tang, PHD · Contact · samitang@163.com · +8613816829057
    • Changlin Mei, MD · Principal investigator
    • Shengqiang Yu, PHD · Sub investigator
    • Xiaojing Tang, PHD · Sub investigator
    • Daoliang Xu, MD · Sub investigator
    • Changhua Liu, MD · Sub investigator
    • Can He, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04088526
Lead sponsor
Shanghai Changzheng Hospital
Responsible party
Changlin Mei (Director of Kidney Institution of PLA, Shanghai Changzheng Hospital) — Principal investigator
First posted
Sep 13, 2019
Start date
Jan 1, 2016
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Sep 20, 2019

Study contacts

Xiaojing Tang, Ph.D.
Contact
samitang@163.com
+8613816829057
Changlin Mei, M.D.
principal investigator · Shanghai Changzheng Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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