NCT06329622RecruitingPhase 3
Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease
Ketosteril Sarcopenia Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 17 Nov 2023
- Start date
- 1 May 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Huashan Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06329622
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 58
- From 1 May 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
- Participated in other interventional clinical trials within 30 days before this study.
Other illness
- Patients with diabetes.
- 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.
- 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.
Other
- Obese/overweight patients (body mass index\>25 kg/m2)
- Patients with poor compliance, unable to follow the study requirements for diet control.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.