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New formula may help dialysis timing save lives

NCT ID NCT03385902

Knowledge-focused Sponsor: The First Affiliated Hospital of Dalian Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether starting dialysis at a specific time, based on a new mathematical formula, could help people with end-stage kidney disease live longer. 388 patients were randomly assigned to start dialysis either at an 'optimal' or 'late' time. Researchers tracked deaths and heart-related events to see if timing made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors decide the best time to start dialysis, potentially improving survival and quality of life for kidney failure patients.
What could go wrong
This is a completed study with 388 participants, but the approach is novel and not yet widely adopted. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

388 people

The number who actually took part.

Started

Apr 2018

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35 * Expected to commence maintenance hemodialysis as their renal replacement treatment * Agreeable to randomization Exclusion Criteria: * Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD) * With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis * Have received or planning to receive a kidney transplant or peritoneal dialysis during the study * Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body ) * Hepatocirrhosis * Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab) * Acute infection within 1 month * Bad habit which is difficult to withdrawal such as alcohol abuse * Poor compliance and could not be treated according to the protocol * Being pregnant, nursing or having a plan for pregnancy * Life expectancy less than 1 year * The investigator confirm that should not enroll in the study with any other cases

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease

Contacts and locations

Locations

  • the First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011, China

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