Muscle loss in kidney disease: could a simple supplement turn the tide?
NCT ID NCT06329622
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial investigates whether Ketosteril, a keto acid supplement taken with a low-protein diet, can improve muscle mass and strength in people with chronic kidney disease (CKD) stages 3-4 who also have sarcopenia (muscle wasting). The study compares the supplement plus diet against diet alone over six months. The goal is to see if Ketosteril can reverse muscle loss without putting extra strain on the kidneys.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketosteril (a keto acid supplement) plus a low-protein diet
- What this could lead to
- If it works, this could offer a way to treat muscle wasting in kidney disease patients without overloading the kidneys.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. Ketosteril may not improve muscle mass or could cause side effects like electrolyte imbalances.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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. 3. Patient can walk normally. 4. Provide the written informed consent. Exclusion Criteria: 1. Patients with diabetes. 2. Obese/overweight patients (body mass index\>25 kg/m2) 3. Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis). 4. Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months. 5. Patients with acute infection (C-reactive protein\>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months. 6. Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure. 7. Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction. 8. Patients with hypercalcemia and amino acid metabolism disorder. 9. Those who are allergic to the active ingredients or other excipients of the Ketosteril. 10. Patients with poor compliance, unable to follow the study requirements for diet control. 11. Participated in other interventional clinical trials within 30 days before this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan hospital, Fudan university
RECRUITINGShanghai, 200040, China
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