Renal DialysisPhase 4NCT05673239
Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients
A Phase 4 study testing Levocarnitine Injection in people with Renal Dialysis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Levocarnitine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance hemodialysis patients;
- 18 years<80 years;
- Have clear consciousness and independent behavior ability;
- Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.
Who cannot join
- Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
- Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
- Patients who have used L-carnitine within 2 weeks.
- Hematological system tumor or tumor;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
About this study
Official title: Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study
This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.
- Conditions
- Renal Dialysis
- Being tested
- Levocarnitine Injection
- Keywords
- Renal Dialysis, Cardiac Function Tests, real-world study, multicenter, prospective, non-randomized, controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocarnitine InjectionDrug
The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form. Receives: Drug: Levocarnitine Injection |
| Control group | No intervention | The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Left ventricular ejection fraction
Measured: baseline and week 12
Secondary outcomes (8)
Change from baseline in Brain natriuretic peptide level
Measured: baseline ,week 4 and week 12
Change from baseline in left ventricular short axis shortening rate
Measured: baseline and week 12
Change from baseline in stroke volume
Measured: baseline and week 12
Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods
Measured: baseline and week 12
Change from baseline in serum albumin
Measured: baseline and week 12
Change from baseline in upper arm circumference
Measured: baseline and week 12
Change from baseline in prealbumin
Measured: baseline and week 12
Change from baseline in hemoglobin
Measured: baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start15 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673239
- Sponsor's protocol ID
- 2022-ZKNT-001
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study
- ClinicalTrials.gov ID
- NCT05673239
- Acronym / sponsor ID
- 2022-ZKNT-001
- Conditions
- Renal Dialysis
- Keywords
- Renal Dialysis, Cardiac Function Tests, real-world study, multicenter, prospective, non-randomized, controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Levocarnitine InjectionThe patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form. |
| Control group | No intervention | –The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Maintenance hemodialysis patients;
- 18 years<80 years;
- Have clear consciousness and independent behavior ability;
- Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.
Key exclusion criteria (4 listed)
- Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
- Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
- Patients who have used L-carnitine within 2 weeks.
- Hematological system tumor or tumor;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levocarnitine InjectionThe patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day | Drug | Test group |
Primary outcome
Change from baseline in Left ventricular ejection fraction
Time frame: baseline and week 12
8 secondary outcomes
Change from baseline in Brain natriuretic peptide level
Time frame: baseline ,week 4 and week 12
Change from baseline in left ventricular short axis shortening rate
Time frame: baseline and week 12
Change from baseline in stroke volume
Time frame: baseline and week 12
Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods
Time frame: baseline and week 12
Change from baseline in serum albumin
Time frame: baseline and week 12
Change from baseline in upper arm circumference
Time frame: baseline and week 12
Change from baseline in prealbumin
Time frame: baseline and week 12
Change from baseline in hemoglobin
Time frame: baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Renal Dialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
RecruitingObservational study
Il Registro Italiano di Dialisi Pediatrica (RIDP) - Italian Registry of Pediatric Dialysis
Dialysis, Kidney Transplantation
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocarnitine Injection in people with Renal Dialysis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Left ventricular ejection fraction (time frame: baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.