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Ketosteril Sarcopenia Chronic Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Huashan hospital, Fudan university
RECRUITING
Shanghai
Contact Information
Primary
Mengjing Wang, PhD, MD
fiyona27@126.com
02152889393
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 58
Treatments
Experimental: Intervention
In the intervention group, low-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. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.
Active_comparator: Control
In the control group, low-protein diet (0.6-0.8g protein/kg body weight/day) and the target energy intake of 25-30kcal/kg body weight/day will be prescribed for 9 months
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov