Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
2
kidney disease
To determine the effect of Ketoanalogue supplementation on sarcopenia at 12 months in patients with stage 4 or 5 CKD and dietary protein intake between 0.6 and 0.8 g/kg/d
Key facts
- Sponsor
- CHU Gabriel-Montpied
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 5 Jan 2026 → ongoing
- Decision date (initial)
- 2025-01-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fresenius Kabi
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine the effect of Ketoanalogue supplementation on sarcopenia at 12 months in patients with stage 4 or 5 CKD and dietary protein intake between 0.6 and 0.8 g/kg/d
Secondary objectives 3
- To determine the effects of KA supplementation in patients with stage 4 or 5 CKD and dietary protein intake between 0.6 and 0.8 g/kg/d on decline of renal function
- To determine the effects of KA supplementation on mineral and bone disorders
- To determine the effects of KA supplementation on metabolism
Conditions and MedDRA coding
kidney disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Men or women older than 18 years
- Stage 4 or 5 Chronic Kidney Disease (CKD) (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2)
- Protein intake 0.6-0.8 g/kg/d (estimated with dietary survey)
- patient with social security cover
- Written informed consent
Exclusion criteria 10
- 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
- Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent
- Hypersensitivity to the active substances in Ketosteril
- Hypercalcaemia
- Patient under a legal protection (curatorship or tutorship)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Muscle mass index measured by DEXA (appendicular lean mass kg/m²) at 12 months. Appendicular muscle mass is the sum of the lean muscle mass of the upper and lower extremities.
Secondary endpoints 14
- Weight and BMI at 3, 6, 12 months
- Concentration of albumin, prealbumin and CRP at 3, 6, 9 and 12 months
- Serum lipids and glycemia at 12 months
- Skin fold and mid arm muscle circumference
- Grip strength measured by dynamometry at 12 months
- Muscle performance evaluated by walking speed test over 4 meters at 12 months
- Serum Calcium and phosphate at 3, 6, 9 and 12 months
- Parathormone at 3, 6, 9 and 12 months
- 25OH Vitamin D2 + D3 at 12 months
- Bone mineral density measured by DEXA at 12 months
- Use and dosage of phosphate binders
- Time to renal replacement therapy start (or transplantation?)
- Estimated GFR using 2012 CKD EPI creatinine and cystatin C equation at 12 months
- Proteinuria at 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ketosteril Ketoacid film-coated tablets
PRD1170228 · Product
- Active substance
- L-Lysine Acetate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 67 mg/kg milligram(s)/kilogram
- Max total dose
- 24455 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- V06DD — AMINO ACIDS, INCL. COMBINATIONS WITH POLYPEPTIDES
- Marketing authorisation
- 20090352
- MA holder
- FRESENIUS KABI BULGARIA EOOD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU Gabriel-Montpied
- Sponsor organisation
- CHU Gabriel-Montpied
- Address
- 58 Rue Montalembert
- City
- Clermont Ferrand
- Postcode
- 63000
- Country
- France
Scientific contact point
- Organisation
- CHU Gabriel-Montpied
- Contact name
- Lise Laclautre
Public contact point
- Organisation
- CHU Gabriel-Montpied
- Contact name
- Lise Laclautre
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 100 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Aura Sante
nephrology, 8 Rue Du Colombier, 63400, Chamalieres
University Hospital Of Clermont-Ferrand
nephrology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-01-05 | 2026-01-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516764-29-00 | 4 |
| Protocol (for publication) | D1_Protocol_2024-516764-29-00_SOC | 1 |
| Protocol (for publication) | D1_Protocol_2024-516764-29-00_TC | 4 |
| Protocol (for publication) | D1_protocol-signature_2024-516764-29-00 | 4 |
| Protocol (for publication) | D4_Patient facing document_card | 1 |
| Protocol (for publication) | D4_Patient facing document_diary | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment-arrangements | 1 |
| Subject information and informed consent form (for publication) | L1-SIS-and-ICF_patient_KetoProtAction | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_RCP-Ketosteril | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_ENG_2024-516764-29-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_FR_2024-516764-29-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | France | Acceptable 2025-01-08
|
2025-01-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-31 | France | Acceptable 2025-09-19
|
2025-09-19 |