Cardiac ComplicationsPhase 4NCT00173706
Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
A Phase 4 study testing L-Carnitine Injection in people with Cardiac Complications and Signs and Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a study designed to test the hypothesis that treatment with L-carnitine will improve the quality of life and some specific symptoms and signs in patients with renal failure submitted to hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Complications, Signs and Symptoms, Muscle Weakness
- What is being tested?
- L-Carnitine Injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the following criteria will be eligible for participation in this study:
- Male or female adults over 18 years of age
- On hemodialysis for at least one year
- Interdialysis weight gain < 5%
- Bicarbonate dialysis 3 times per week
- Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis)
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- Have one of the following symptoms and signs that have not responded to diet or pharmacological intervention:
- persistent weakness affecting daily life
- malnutrition
- anemia (hemoglobin [Hb] < 12 g/dl; hematocrit [Hct] < 30%)
- experiencing intradialytic complications (cramping, muscular pain, hypotension, hypertension, head-ache)
- On regular treatment with vitamin B12 and folates
- Normal iron status (ferritin > 100 ng/ml; transferrin saturation [TSAT] > 20%)
- Informed consent obtained
- Patients with diabetes mellitus are allowed to enter the study if they have stable glycaemic control on diet or pharmacological treatment.
Who cannot join
- Patients displaying one or more of the following criteria will not be eligible for participation in this study:
- Severe uncontrolled hypertension (systolic > 170; diastolic > 115) outside of dialysis
- Some patients have echocardiogram (ECHO) defined chronic heart failure. Patients with New York Heart Association (NYHA) class II and class III can be admitted. Patients with class IV must be excluded. Some patients have angina. Patients with stable effort angina well controlled by treatment can be recruited. Absolute exclusion for angina at rest.
- Major hepatic diseases - chronic active (aggressive) hepatitis or cirrhosis
- Systemic haematological diseases and tumours
- Uncontrollable diabetes
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- History of drug and alcohol abuse
- Positive screening for HIV antibodies
- Life expectancy of less than one year
- Uncontrolled hyperparathyroidism (patients with stable bone status can be recruited)
- Use of immunodepressants during the preceding 4 weeks
- Changes in corticoid therapy in the preceding 4 weeks
- Use of experimental drugs during the preceding 4 months
- Use of L-carnitine during the preceding 4 months
- Informed consent not obtained
- Pregnancy
- Patients already included in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 110
Kwan-Dun Wu, Ph.D, 886-2-23123456 ext. 2117, kdw@ha.mc.ntu.edu.tw
About this study
This is a study designed to test the hypothesis that treatment with L-carnitine will improve the quality of life and some specific symptoms and signs in patients with renal failure submitted to hemodialysis.
Read the detailed description
L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for beta-oxidation. A lack of carnitine in hemodialysis patients is caused by insufficient carnitine synthesis and particularly by the loss through dialytic membranes, leading in some patients to carnitine depletion with a relative increase of esterified forms. Many studies have shown that L-carnitine supplementation leads to improvements in several complications seen in uremic patients, including cardiac complications, impaired exercise and functional capacities, muscle symptoms, increased symptomatic intradialytic hypotension, and erythropoietin-resistant anemia, normalizing the reduced carnitine palmitoyl transferase activity in red cells.
- Conditions
- Cardiac Complications, Signs and Symptoms, Muscle Weakness, Anemia, Hypotension
- Being tested
- L-Carnitine Injection
- Keywords
- L-Carnitine, hemodialysis, cardiac complications, impaired exercise and functional capacities, muscle symptoms, intradialytic hypotension, erythropoietin-resistant anemia
- Medical subject headings
- Signs and Symptoms, Muscle Weakness, Anemia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
weakness
improvement of hypotension and hematology profile
reduction of erythropoietin requirement
increase of plasma carnitine concentration
Secondary outcomes (4)
including all the components of the primary endpoints for their further assessment
improvement of the nutritional indexes
intradialytic complications (muscle symptoms, dyspnea, palpitations)
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, Ph.D, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173706
- Sponsor's protocol ID
- 930404
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 1 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT00173706
- Acronym / sponsor ID
- 930404
- Conditions
- Cardiac Complications, Signs and Symptoms, Muscle Weakness, Anemia, Hypotension
- Keywords
- L-Carnitine, hemodialysis, cardiac complications, impaired exercise and functional capacities, muscle symptoms, intradialytic hypotension, erythropoietin-resistant anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2004
- First posted
- 15 Sep 2005 (estimated)
- 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 is a study designed to test the hypothesis that treatment with L-carnitine will improve the quality of life and some specific symptoms and signs in patients with renal failure submitted to hemodialysis.
Detailed description
L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for beta-oxidation. A lack of carnitine in hemodialysis patients is caused by insufficient carnitine synthesis and particularly by the loss through dialytic membranes, leading in some patients to carnitine depletion with a relative increase of esterified forms. Many studies have shown that L-carnitine supplementation leads to improvements in several complications seen in uremic patients, including cardiac complications, impaired exercise and functional capacities, muscle symptoms, increased symptomatic intradialytic hypotension, and erythropoietin-resistant anemia, normalizing the reduced carnitine palmitoyl transferase activity in red cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female adults over 18 years of age
- On hemodialysis for at least one year
- Interdialysis weight gain < 5%
- Bicarbonate dialysis 3 times per week
- Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis)
Key exclusion criteria (17 listed)
- Patients displaying one or more of the following criteria will not be eligible for participation in this study:
- Severe uncontrolled hypertension (systolic > 170; diastolic > 115) outside of dialysis
- Some patients have echocardiogram (ECHO) defined chronic heart failure. Patients with New York Heart Association (NYHA) class II and class III can be admitted. Patients with class IV must be excluded. Some patients have angina. Patients with stable effort angina well controlled by treatment can be recruited. Absolute exclusion for angina at rest.
- Major hepatic diseases - chronic active (aggressive) hepatitis or cirrhosis
- Systemic haematological diseases and tumours
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 |
|---|---|---|
| L-Carnitine Injection | Drug | – |
Primary outcome
weakness
improvement of hypotension and hematology profile
reduction of erythropoietin requirement
increase of plasma carnitine concentration
4 secondary outcomes
including all the components of the primary endpoints for their further assessment
improvement of the nutritional indexes
intradialytic complications (muscle symptoms, dyspnea, palpitations)
quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2006.
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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.
Kwan-Dun Wu, Ph.D study director
National Taiwan University Hospital
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 L-Carnitine Injection in people with Cardiac Complications and Signs and Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
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 15 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Mar 2006. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwan-Dun Wu, Ph.D (886-2-23123456 ext. 2117, kdw@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weakness. The study lists 4 primary outcomes in all. 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 1 Mar 2006.