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Muscle-Saving supplement tested in kidney patients

NCT ID NCT07374042

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a ketoanalogue supplement (Ketosteril) can prevent muscle loss in 100 adults with stage 4 or 5 chronic kidney disease who are on a moderately low-protein diet. Participants take the supplement daily for a period, and researchers measure changes in muscle mass using DEXA scans. The goal is to find a way to help patients maintain strength and delay the need for dialysis.

What this could mean

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

Active substance
keto acid analog (Ketosteril)
What this could lead to
If it works, this could offer a way to protect muscle mass in people with advanced kidney disease, potentially delaying the need for dialysis.
What could go wrong
This is a phase 3 trial, but it's still relatively small (100 participants) and focuses on a specific patient group. The supplement may not prevent muscle loss, and some people may find the diet hard to follow.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

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

Started

Jan 2026

Expected to finish

Jan 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 to 100 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: * Men or women * Older than 18 years of age * Stage 4 or 5 CKD (eGFR with CKD-EPI 2009 creatinine equation \< 30 mL/min/m2), whitout renal replacement therapy or kidney transplantation * Protein intake 0.6-0.8 g/kg/d (estimated with Moroni formula) * Social security cover * Written informed consent Exclusion Criteria: * Hospitalization in the past 3 months * Corticosteroids (\> 7.5 mg/d), cytotoxic or immunosuppressive drugs * Severe symptomatic heart (NYHA 3 or 4) or liver failure (Child Pugh B or C) * Respiratory failure requiring oxygenotherapy * Ongoing infection, autoimmune disease or cancer * Pregnant (e.g., positive human chorionic gonadotrophin \[HCG\] test) or lactating patients * Risk of pregnancy: any woman who does not fulfil one of the following criteria: * post-menopausal (aged \> 45 years with amenorrhea for more than 2 years, or of any age with amenorrhea for more than 6 months and an FSH level \> 40 mUI / mL) * permanent sterilisation (e.g., occlusion/bilateral ligature of the fallopian tubes, hysterectomy, bilateral salpingectomy, bilateral ovariectomy) or constitutional sterility * of childbearing age and using an efficient method of contraception, begun at least 28 days before inclusion. Efficient contraception methods are: oral, injectable or implantable hormonal methods intra-uterine devices sterilisation of the male partner if he is the sole partner abstinence, if compatible with the preferred and usual lifestyle of the individual NB: if child bearing potential changes during the study, the woman must start taking one of the efficient methods of contraception as described above. * Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent * Patients unwilling to participate in the study * Hypersensitivity to the active substances in Ketosteril® * Hypercalcaemia * Hypophosphatemia * Patient under a legal protection (curatorship or tutorship)

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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

  • CHU de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

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