Chronic Kidney DiseasePhase 3NCT06329622
Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease
A Phase 3 study testing low-protein diet + Ketosteril and low-protein diet in people with Chronic Kidney Disease and Sarcopenia, run by Huashan Hospital at 1 site in China.
Trial summary
The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease, Sarcopenia
- What is being tested?
- low-protein diet + Ketosteril and low-protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jun 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR<60 ml/(min*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.
- Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (< 28 kg for males, < 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (< 1.0 m/s) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (< 7.0 kg/m2 for males and < 5.7 kg/m2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.
- Patient can walk normally.
- Provide the written informed consent.
Who cannot join
- Patients with diabetes.
- Obese/overweight patients (body mass index>25 kg/m2)
- Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
- Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
- Patients with acute infection (C-reactive protein>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
- Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.
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- Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.
- Patients with hypercalcemia and amino acid metabolism disorder.
- Those who are allergic to the active ingredients or other excipients of the Ketosteril.
- Patients with poor compliance, unable to follow the study requirements for diet control.
- Participated in other interventional clinical trials within 30 days before this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan hospital, Fudan university
Shanghai, 200040
Mengjing Wang, PhD, MD, 021-52889393, fiyona27@126.com
About this study
Official title: Ketosteril Sarcopenia Chronic Kidney Disease
The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Being tested
- low-protein diet + Ketosteril, low-protein diet
- Keywords
- CKD, sarcopenia
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-protein diet + KetosterilCombination product
low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day.
low-protein dietDietary supplement
low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention group, low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day. Receives: Combination Product: low-protein diet + Ketosteril |
| Control | Active comparator | In the control group, low-protein diet (0.6-0.8g protein/kg body weight/day) and the target energy intake of 25-30kcal/kg body weight/day will be prescribed for 9 months Receives: Dietary Supplement: low-protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle mass index (SMI)
SMI=skeletal muscle weight/(height×height)，the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m^2
Measured: six months after the intervention
Secondary outcomes (5)
changes in eGFR(ml/min/1.73m2)
From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)
Measured: six months after the intervention
serum albumin(g/l)
From baseline to the 6th month, changes in serum albumin(g/l)
Measured: six months after the intervention
grip strength(kg)
From baseline to the 6th month,changes in grip strength(kg)
Measured: six months after the intervention
BMI(kg/m2)
From baseline to the 6th month,changes in BMI(kg/m2)
Measured: six months after the intervention
6m walking speed(s)
From baseline to the 6th month,changes in 6m walking speed(s)
Measured: six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, PhD, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329622
- Sponsor's protocol ID
- KY2023-972
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon request pending
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketosteril Sarcopenia Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06329622
- Acronym / sponsor ID
- KY2023-972
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Keywords
- CKD, sarcopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Mar 2024 (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.
The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: low-protein diet + KetosterilIn the intervention group, low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day. |
| Control | Active comparator | Dietary Supplement: low-protein dietIn the control group, low-protein diet (0.6-0.8g protein/kg body weight/day) and the target energy intake of 25-30kcal/kg body weight/day will be prescribed for 9 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR<60 ml/(min*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.
- Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (< 28 kg for males, < 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (< 1.0 m/s) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (< 7.0 kg/m2 for males and < 5.7 kg/m2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.
- Patient can walk normally.
- Provide the written informed consent.
Key exclusion criteria (11 listed)
- Patients with diabetes.
- Obese/overweight patients (body mass index>25 kg/m2)
- Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
- Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
- Patients with acute infection (C-reactive protein>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
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 |
|---|---|---|
| low-protein diet + Ketosterillow-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. | Combination product | Intervention |
| low-protein dietlow-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day. | Dietary supplement | Control |
Primary outcome
skeletal muscle mass index (SMI)
Time frame: six months after the intervention
SMI=skeletal muscle weight/(height×height)，the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m^2
5 secondary outcomes
changes in eGFR(ml/min/1.73m2)
Time frame: six months after the intervention
serum albumin(g/l)
Time frame: six months after the intervention
grip strength(kg)
Time frame: six months after the intervention
BMI(kg/m2)
Time frame: six months after the intervention
6m walking speed(s)
Time frame: six months after the intervention
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 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data will be made available upon request pending
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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.
Jing Chen, PhD, MD principal investigator
Huashan Hospital
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 low-protein diet + Ketosteril and low-protein diet in people with Chronic Kidney Disease and Sarcopenia, run by Huashan Hospital at 1 site in China.
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 4 inclusion and 11 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 Jul 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 China. 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 Mengjing Wang, PhD, MD (02152889393, fiyona27@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle mass index (SMI) (time frame: six months after the intervention). 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 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.