Muscle-Saving supplement tested in kidney patients
NCT ID NCT07374042
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 Hide 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic kidney disease stage 5 are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGClermont-Ferrand, 63000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could pistachios be safe for failing kidneys? trial tests a forbidden snack
- A conversation starter for kidney care: can a checklist give older patients a stronger voice?
- Choosing dialysis or transplant: does a shared approach lead to better decisions?
- Can light therapy speed up dialysis fistula healing?
- Could a little fat be the key to better dialysis access?
- Special foods could make Low-Protein diets easier for kidney patients