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Muscle loss in kidney disease: could a simple supplement turn the tide?

NCT ID NCT06329622

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Huashan hospital, Fudan university

    RECRUITING

    Shanghai, 200040, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.