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Can a nutrient cocktail during dialysis save muscle?

NCT ID NCT04094038

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a special nutrient mixture (Olimel N12) during hemodialysis can help prevent muscle loss and improve quality of life in people with end-stage kidney disease. About 166 patients will receive either the nutrient infusion or a simple glucose solution during their regular dialysis sessions. The main goal is to see if lean tissue mass changes over time.

What this could mean

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

Active substance
Olimel N12 (a mixture of glucose, lipids, and amino acids given intravenously during dialysis)
What this could lead to
If it works, this could provide a way to prevent muscle loss and improve quality of life for people on long-term hemodialysis.
What could go wrong
This is a phase 4 study, but previous evidence for this approach is weak. The benefit may be small or not apply to all patients, and there are risks like infection or allergic reactions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 166 people

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

Started

Sep 2019

Expected to finish

Jul 2026

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: * Undergoing chronic hemodialysis Exclusion Criteria: * Life expectancy \< 6 months * Planned kidney transplant within 4 months * Severe overhydration leading to respiratory insufficiency * Parenteral nutrition within four weeks prior to screening * Severe hepatic insufficiency * Pregnancy * Unipolar pacemaker with a very low sensitivity threshold * Active treatment for infection * Acute myocardial infarction * Circulatory shock * Hypersensitivity for any Olimel N12 ingredient or excipient

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Conditions

The condition(s) this trial relates to.

chronic kidney disease dialysis disequilibrium syndrome end stage renal failure Malnutrition nutritional deficiency disease Sarcopenia

As listed by the trial registrant

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

End-stage renal disease Hemodialysis complication Malnutrition Sarcopenia

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, Netherlands

  • Franciscus Gasthuis & Vlietland

    Rotterdam, Netherlands

More trials for these conditions

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