Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

October 10, 2024 updated by: Chen Jing, Huashan Hospital

Ketosteril Sarcopenia Chronic Kidney Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mengjing Wang, PhD, MD
  • Phone Number: 02152889393
  • Email: fiyona27@126.com

Study Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Combination product: 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.
Active Comparator: 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
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
skeletal muscle mass index (SMI)
Time Frame: six months after the intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in eGFR(ml/min/1.73m2)
Time Frame: six months after the intervention
From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)
six months after the intervention
serum albumin(g/l)
Time Frame: six months after the intervention
From baseline to the 6th month, changes in serum albumin(g/l)
six months after the intervention
grip strength(kg)
Time Frame: six months after the intervention
From baseline to the 6th month,changes in grip strength(kg)
six months after the intervention
BMI(kg/m2)
Time Frame: six months after the intervention
From baseline to the 6th month,changes in BMI(kg/m2)
six months after the intervention
6m walking speed(s)
Time Frame: six months after the intervention
From baseline to the 6th month,changes in 6m walking speed(s)
six months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Chen, PhD, MD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2023-972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be made available upon request pending

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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