Using Ketosteril to Improve Muscle Loss in Kidney Disease Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Ketosteril on sarcopenia in patients with chronic kidney disease (CKD) stages 3-4. Participants will be assigned to receive either a low-protein diet with Ketosteril or a low-protein diet alone. The study aims to determine if Ketosteril can enhance muscle strength and function without worsening kidney function. The trial will assess various physical performance metrics and muscle mass to evaluate the intervention's effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan hospital, Fudan university
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Jing Chen, PhD, MD — Huashan Hospital
• Study coordinator: Mengjing Wang, PhD, MD
• Email: fiyona27@126.com
• Phone: 02152889393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.