Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Ketosteril Sarcopenia Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329622
• Other study ID #: KY2023-972
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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: ? Muscle strength: grip strength (< 28 kg for males, < 18 kg for females); ? 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); ? 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 ?, sarcopenia can be diagnosed if at least one of the first two items is met.

3. Daily dietary protein intake = 40 grams.

4. Patient can walk normally.

5. 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sarcopenia

Intervention

Combination Product:
• low-protein diet + Ketosteril
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.

Dietary Supplement:
• low-protein diet
low-protein diet (0.6g protein/kg body weight/day)

Locations

Country	Name	City	State
China	Nephrology, Huashan hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skeletal muscle mass index (SMI)	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	six months after the intervention
Secondary	changes in eGFR(ml/min/1.73m2)	From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)	six months after the intervention
Secondary	serum albumin(g/l)	From baseline to the 6th month, changes in serum albumin(g/l)	six months after the intervention
Secondary	grip strength(kg)	From baseline to the 6th month,changes in grip strength(kg)	six months after the intervention
Secondary	BMI(kg/m2)	From baseline to the 6th month,changes in BMI(kg/m2)	six months after the intervention
Secondary	6m walking speed(s)	From baseline to the 6th month,changes in 6m walking speed(s)	six months after the intervention