Using Ketosteril to Improve Muscle Loss in Kidney Disease Patients

Ketosteril Sarcopenia Chronic Kidney Disease

This study is testing if adding Ketosteril to a low-protein diet can help people with chronic kidney disease build muscle and improve strength without harming their kidneys.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06329622 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with CKD stage 3-4 and sarcopenia who can walk normally.

Not a fit: Patients with diabetes or those who are obese/overweight may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve muscle health and quality of life for patients with chronic kidney disease.

How similar studies have performed: Other studies have explored interventions for sarcopenia in CKD, but the specific use of Ketosteril in this context is relatively novel.

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.

Where this trial is running

Shanghai

• Huashan hospital, Fudan university — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jing Chen, PhD, MD — Huashan Hospital
• Study coordinator: Mengjing Wang, PhD, MD

Conditions Chronic Kidney Disease; Sarcopenia; CKD; sarcopenia