NCT07374042 Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 100 participants in total. It began in 2026-01-05 with a primary completion date of 2030-01.

Brief Summary

Chronic kidney disease (CKD) complicates many pathologies and the rapid increase in its prevalence constitutes a major public health concern. Whatever the cause of kidney failure, high protein consumption is a factor of progression to end-stage kidney disease. A low-protein (0.6 g/kg/d) or a very low-protein (0.3 g/kg/d) diet associated with supplementation with amino acids and/or keto acid analogues (KA) slows down renal function deterioration and prolongs the time before dialysis start. Difficulties in strict protein restriction implementation limit its use to a minority of CKD patients and are difficult to implement in real life. Recently KDOQI guidelines have recommended a dietary protein intake of 0.55 to 0.6 g/kg/d in CKD 3 to 5 non-diabetic patients "metabolically stable" and 0.6 to 0.8 g/kg/d in diabetic patients. However, the International Society of Renal Nutrition and Metabolism and the French guidelines about management of CKD propose to maintain a protein intake between 0.6 and 0.8 g/kg/d for all patients and as near as possible to 0.6 g/kg/d. This is because for a population, a mean value of 0.66 g/kg/d insures that 95% of patients are above 0.55 g/kg/d (the minimum requirement to avoid a negative nitrogen balance). Experimental studies and few clinical studies suggest a protective effect of KA supplementation on uremic sarcopenia. Interestingly this effect is also observed in patients with a protein intake of 0.6 to 0.8 g/kg/d and with a dose of KA reduced by half compared to the dose used with VLPD. Moreover, in a preliminary study, we found a nephroprotective effect of KA (1 tablet/5kg body weight) in patients with an average dietary protein intake of 0.7 g/kg/d suggesting a specific effect of KA beyond protein restriction. The hypothesis is therefore that KA treatment (1 tablet/10kg), together with a dietary protein intake between 0.6 and 0.8g/kg/d, prevent muscle mass loss in patients with stages 4 and 5 CKD. If these results were confirmed, this could expand the population that could benefit from KA supplementation.

Eligibility 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)

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