Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHuashan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with diabetes.
Obese/overweight patients (body mass index>25 kg/m2)
Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
low-protein diet + Ketosteril
Combination productlow-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day.
low-protein diet
Dietary supplementlow-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
six months after the interventionSecondary outcomes
1
changes in eGFR(ml/min/1.73m2)
From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)
Time frame
six months after the intervention2
serum albumin(g/l)
From baseline to the 6th month, changes in serum albumin(g/l)
Time frame
six months after the intervention3
grip strength(kg)
From baseline to the 6th month,changes in grip strength(kg)
Time frame
six months after the intervention4
BMI(kg/m2)
From baseline to the 6th month,changes in BMI(kg/m2)
Time frame
six months after the interventionSponsors and contacts
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Source ClinicalTrials.gov