Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

NCT ID: NCT06329622

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Chronic Kidney Disease; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

low-protein diet + Ketosteril

Intervention Type: COMBINATION_PRODUCT

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.

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

Group Type: ACTIVE_COMPARATOR

low-protein diet

Intervention Type: DIETARY_SUPPLEMENT

low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.

Interventions

low-protein diet + Ketosteril

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.

Intervention Type: COMBINATION_PRODUCT

low-protein diet

low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Jing

Director of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Chen, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan hospital, Fudan university

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Mengjing Wang, PhD, MD

Role: CONTACT

fiyona27@126.com

02152889393

Facility Contacts

Mengjing Wang, PhD, MD

Role: primary

fiyona27@126.com

021-52889393

Other Identifiers

KY2023-972

Identifier Type: -

Identifier Source: org_study_id