Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

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 forSarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: gripstrength (< 28 kg for males, < 18 kg for females); ② Physical function: is assessedby 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 Artificialskeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (< 7.0kg/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 cardiacfailure within 3 months.

5. Patients with acute infection (C-reactive protein>10 mg/L) or acute exacerbation ofchronic diseases that is not under control within 3 months.

6. Patients with cerebrovascular events, severe liver disease, malignant tumor andmultiple organ failure.

7. Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoralhead, 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 theKetosteril.

10. Patients with poor compliance, unable to follow the study requirements for dietcontrol.

11. Participated in other interventional clinical trials within 30 days before thisstudy.