Actively Recruiting

Phase 3
All Genders
NCT06329622

Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Led by Huashan Hospital · Updated on 2024-10-15

58

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria for CKD stage 3-4 (15 64eGFR <60 ml/(min*1.73m2)) according to the 2012 KDIGO guideline
  • Diagnosed with sarcopenia based on the 2019 Asian Working Group for Sarcopenia criteria: low muscle strength (grip strength <28 kg for males, <18 kg for females), low physical function (walking speed <1.0 m/s or 5STS 6512 s or SPPB 649), and low muscle mass (ASM <7.0 kg/m2 for males and <5.7 kg/m2 for females)
  • Able to walk normally
  • Provide written informed consent
Not Eligible

You will not qualify if you...

  • Have diabetes
  • Are obese or overweight (body mass index >25 kg/m2)
  • Previously received renal replacement therapy (kidney transplantation, hemodialysis, peritoneal dialysis)
  • Experienced new cardiovascular events or uncontrolled acute/chronic heart failure within 3 months
  • Have acute infection (C-reactive protein >10 mg/L) or uncontrolled acute exacerbation of chronic disease within 3 months
  • Have cerebrovascular events, severe liver disease, malignant tumors, or multiple organ failure
  • Have osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia, or cognitive dysfunction
  • Have hypercalcemia or amino acid metabolism disorders
  • Are allergic to Ketosteril or its ingredients
  • Have poor compliance or cannot follow diet control requirements
  • Participated in other interventional clinical trials within 30 days before this study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Huashan hospital, Fudan university

Shanghai, China, 200040

Actively Recruiting

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Research Team

M

Mengjing Wang, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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