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

NCT07374042 | Recruiting Phase 3

• 2 other identifiers: RBHP 2023 ANIORT 22024-516764-29-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

• Appendicular muscle mass measured by DEXA

  measured by DEXA

  at 12 months

Study Arms (2)

Keto acid analog

EXPERIMENTAL

Current practice + Keto acid analog (1 tablet / 10 kg body weight) Current practice: protein intake target of 0.6 g/kg/d in order to achieve a dietary protein intake of 0.6 to 0.8 g/kg/d (50% animal protein 50 % plant protein) and total energy intake of 25-35 kcal/kg/d.

Drug: Keto Acid

Control

NO INTERVENTION

Current practice: protein intake target of 0.6 g/kg/d in order to achieve a dietary protein intake of 0.6 to 0.8 g/kg/d (50% animal protein 50 % plant protein) and total energy intake of 25-35 kcal/kg/d.

Interventions

Keto Acid DRUG

Keto acid analog Ketosteril (1 tablet / 10 kg body weight)

Keto acid analog

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Keto Acids

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals

Study Officials

• Julien Aniort

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+334.73754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 28, 2026

Record last verified: 2025-01

Locations

FR (1)