Tests Ketosteril with a low-protein diet for muscle loss in kidney disease
Tests Ketosteril added to a low-protein diet in people with kidney disease and muscle loss.
Plain-language title generated from the registry record
Registry title: Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06329622
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis); Participated in other interventional clinical trials within 30 days before this study; 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; Obese/overweight patients (body mass index>25 kg/m2); Patients with poor compliance, unable to follow the study requirements for diet control.