Ketoanalogue supplements to protect muscle in advanced chronic kidney disease on a moderately low‑protein diet
Official title: Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet
Run by University Hospital, Clermont-Ferrand · NCT07374042 · Data updated 2026-11-12
This tests whether adding ketoacid/amino‑acid supplements to a moderately low‑protein diet helps protect muscle and slow kidney decline in adults with stage 4–5 chronic kidney disease who are not yet on dialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07374042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with stage 4 or 5 CKD (eGFR <30 mL/min/1.73 m2), not on dialysis or transplanted, who are following a moderately low‑protein diet (about 0.6–0.8 g/kg/day) and can provide informed consent are ideal candidates.
✕Probably not a fit
People with recent hospitalization, active infection, ongoing cancer or autoimmune disease, severe heart or liver failure, respiratory failure requiring oxygen, those on high‑dose steroids or immunosuppressants, pregnant or breastfeeding women, or those unable to follow the dietary requirements are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with stage 4–5 CKD who are already following a moderately low‑protein diet will receive ketoanalogue supplementation and be followed for measures of muscle mass, nutritional status, and kidney function. Clinical visits and laboratory tests will track changes over time and compare outcomes between participants who receive supplementation and those who do not. The protocol targets patients not on dialysis or with a kidney transplant, with protein intake estimated around 0.6–0.8 g/kg/day. The trial is a phase 3 interventional effort run from a single university hospital site.
Why it matters
Potential benefit: If successful, the approach could preserve muscle mass and nutritional status and delay progression to dialysis for people with advanced CKD.
How similar studies have gone: Previous trials and guideline reviews have shown that very‑low‑protein diets supplemented with ketoanalogues can slow renal decline and help maintain nutritional status in selected CKD patients, so this approach has supporting but still limited high‑level evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
CHU de Clermont-Ferrand
Clermont-Ferrand, France Recruiting
Study contacts
- Principal investigator: Julien Aniort — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +334.73754.963
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AdiaVita regenerative therapy for chronic kidney disease
This trial tests whether AdiaVita (umbilical cord blood stem cells and exosomes plus glutathione) can improve kidney function in adults with stage 2–4 chronic kidney disease.
-
Rutgers University Genetics of Kidney Disease
This project will see if genes are linked to kidney disease risk by collecting health surveys and saliva DNA from people 18 and older in the U.S.
-
GLP-1 receptor agonist in people on maintenance dialysis
This test will see if weekly semaglutide is safe and doable for people on long-term dialysis who have type 2 diabetes.
-
Probiotic supplementation to slow kidney disease progression
This study is testing if taking probiotics can help people with moderate to severe chronic kidney disease feel better and slow down the progression of their condition.
-
Testing diuretics to predict kidney disease progression
This study is testing if using diuretics can help predict how quickly chronic kidney disease gets worse in patients.
-
Observational study on kidney transplant rejection predictors in Scotland
This study looks at kidney transplant patients in Scotland to see if certain markers in their urine can help predict if their new kidney might be rejected.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.