Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Phase 3

Recruiting

• Conditions: Sarcopenia; Chronic Kidney Disease
• Interventions: Dietary Supplement: low-protein diet; Combination Product: low-protein diet + Ketosteril

• Registration Number: NCT06329622
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-26
• Study Start: 2024-05-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	low-protein diet	In the control group, low-protein diet (0.6g protein/kg body weight/day) and the target energy intake of 30kcal/kg body weight/day will be prescribed for 9 months
Intervention	low-protein diet + Ketosteril	In the intervention group, low-protein diet (0.6g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 30kcal/kg body weight/day. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6g protein/kg body weight/day) with the target energy intake of 30kcal/kg body weight/day.

Primary Outcome Measures

Name	Time	Method
skeletal muscle mass index (SMI)	six months after the intervention	SMI=skeletal muscle weight/(height×height)，the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m\^2

Secondary Outcome Measures

Name	Time	Method
serum albumin(g/l)	six months after the intervention	From baseline to the 6th month, changes in serum albumin(g/l)
BMI(kg/m2)	six months after the intervention	From baseline to the 6th month,changes in BMI(kg/m2)
6m walking speed(s)	six months after the intervention	From baseline to the 6th month,changes in 6m walking speed(s)
grip strength(kg)	six months after the intervention	From baseline to the 6th month,changes in grip strength(kg)
changes in eGFR(ml/min/1.73m2)	six months after the intervention	From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)

Trial Locations

Locations (1)

Huashan hospital, Fudan university; 🇨🇳 Shanghai, China