Ketoanalogue supplements to protect muscle in advanced chronic kidney disease on a moderately low‑protein diet
Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07374042 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Clermont-Ferrand
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.