Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

NCT06329622 | Recruiting Phase 3 DMC

• 1 other identifier: KY2023-972
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

CKD; sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• changes in eGFR(ml/min/1.73m2)

  six months after the intervention

• serum albumin(g/l)

  six months after the intervention

• grip strength(kg)

  six months after the intervention

• BMI(kg/m2)

  six months after the intervention

• 6m walking speed(s)

  six months after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Combination Product: low-protein diet + Ketosteril

Control

ACTIVE COMPARATOR

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

Dietary Supplement: low-protein diet

Interventions

low-protein diet + Ketosteril 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.

Intervention

low-protein diet 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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with diabetes.
• Obese/overweight patients (body mass index\>25 kg/m2)
• Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
• Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
• Patients with acute infection (C-reactive protein\>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
• Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.
• Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.
• Patients with hypercalcemia and amino acid metabolism disorder.
• Those who are allergic to the active ingredients or other excipients of the Ketosteril.
• Patients with poor compliance, unable to follow the study requirements for diet control.
• Participated in other interventional clinical trials within 30 days before this study.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia

Interventions

Diet, Protein-Restricted; ketosteril

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jing Chen, PhD, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengjing Wang, PhD, MD

CONTACT

02152889393; fiyona27@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)