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Could a simple supplement help dialysis patients need fewer sessions?

NCT ID NCT07699627

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a supplement called Ketosteril, added to the usual diet, can help people who are starting hemodialysis (a treatment for kidney failure) stay on a less frequent schedule longer. The trial includes 70 adults beginning incremental hemodialysis, where sessions start at fewer than three times per week. Researchers will measure how many months patients can maintain this reduced schedule before needing full-dose dialysis.

What this could mean

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

Active substance
Ketosteril (essential amino acids and ketoacids)
What this could lead to
If it works, this could help people starting dialysis delay the need for more frequent sessions, potentially improving quality of life.
What could go wrong
This is a small, early-phase trial (70 people) testing a supplement, so results may not be conclusive or widely applicable. The supplement may not extend the incremental phase or could cause side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

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 years and older

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: * Adult patients (aged 18 years or older) * Able and accepting to give informed consent * Starting iHD in the Centre Hospitalier Le Mans Exclusion Criteria: * Denying informed consent * Acute kidney injury (AKI) * Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months * Cognitive impairment severe enough to limit understanding and acceptance of the study * Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue) * Patient with genetic disease affecting amino acid metabolism * Hypercalcemia defined as calcemia beyond the upper limit of normality according to the laboratory where the test is performed and persisting for at least one month * Hypersensitivity to the active substances or to any of the excipients of Ketosteril * Non-compliance to dialysis prescription * Previous enrolment in a randomized study using Ketosteril * Currently enrolled in another interventional clinical trial * Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Le Mans

    Le Mans, 72000, France

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