Kidney Disease, ChronicPhase 3KETOPROTACTIONNCT07374042
Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)
A Phase 3 study testing Keto Acid in people with Kidney Disease, Chronic, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Keto Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2026to Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Julien Aniort
About this study
Official title: Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet
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).
Read more
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
- Being tested
- Keto Acid
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto AcidDrug
Keto acid analog Ketosteril (1 tablet / 10 kg body weight)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular muscle mass measured by DEXA
measured by DEXA
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start5 Jan 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Aniort, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374042
- Sponsor's protocol ID
- RBHP 2023 ANIORT 2
- Other IDs
- 2024-516764-29-00
- Acronym
- KETOPROTACTION
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet
- ClinicalTrials.gov ID
- NCT07374042
- Acronym / sponsor ID
- KETOPROTACTION / RBHP 2023 ANIORT 2
- Conditions
- Kidney Disease, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto acid analog | Experimental | Drug: Keto AcidCurrent 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keto AcidKeto acid analog Ketosteril (1 tablet / 10 kg body weight) | Drug | Keto acid analog |
Primary outcome
Appendicular muscle mass measured by DEXA
Time frame: at 12 months
measured by DEXA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien Aniort principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Keto Acid in people with Kidney Disease, Chronic, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+334.73754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular muscle mass measured by DEXA (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.