Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Ketosteril Sarcopenia Chronic Kidney Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease; Sarcopenia
• Intervention / Treatment: Combination product: low-protein diet + Ketosteril; Dietary supplement: low-protein diet

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200040
    • Nephrology, Huashan hospital
    • Contact: Mengjing Wang; Phone Number: +8613764676029; Email: fiyona27@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	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.
Active Comparator: Control; 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	Dietary supplement: low-protein diet; low-protein diet (0.6g protein/kg body weight/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
serum albumin(g/l)	From baseline to the 6th month, changes in serum albumin(g/l)	six months after the intervention
grip strength(kg)	From baseline to the 6th month,changes in grip strength(kg)	six months after the intervention
BMI(kg/m2)	From baseline to the 6th month,changes in BMI(kg/m2)	six months after the intervention
6m walking speed(s)	From baseline to the 6th month,changes in 6m walking speed(s)	six months after the intervention

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CKD; sarcopenia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Renal Insufficiency; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Sarcopenia
• Other Study ID Numbers: KY2023-972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be made available upon request pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No