Clinical trial NCT06329622: Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease
Official title: Ketosteril Sarcopenia Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Kidney Disease
Sarcopenia
Keywords: CKD
sarcopenia
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: skeletal muscle mass index (SMI)
timeFrame: six months after the intervention
Secondary outcomes:
measure: changes in eGFR(ml/min/1.73m2)
timeFrame: six months after the intervention
measure: serum albumin(g/l)
timeFrame: six months after the intervention
measure: grip strength(kg)
timeFrame: six months after the intervention
measure: BMI(kg/m2)
timeFrame: six months after the intervention
measure: 6m walking speed(s)
timeFrame: six months after the intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital, Fudan university
Study officials:
affiliation: Huashan Hospital
name: Jing Chen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: