Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient (NCT02794142) | Clinical Trial Compass
TerminatedNot Applicable
Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient
Stopped: Lack of recruitment
France32 participantsStarted 2015-05
Plain-language summary
In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has previously been reported. This muscle impairment constitutes an independent prognosis factor in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment. The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore, the aim of the present study is to investigate the role of the muscle mitochondrial density on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and oxidative stress in HD patients vs. healthy matched controls.
In order to assess the effect of the oxidative stress and inflammation on the muscle impairment in HD patients, muscle function assessements will be performed after renal transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient group.
No therapeutic intervention will be tested in the present study.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 40-80 years old
* less than 150min by week of moderate to vigorous physical activity
* Chronic renal failure (glomerular filtration rate less than 15mL by min) requiring hemodialysis
* Patient placed on the kidney transplant waiting list of MontpellierCHU
* No indication against temporary kidney transplant
* Review cardiovascular older than two years
* Patient not under guardianship or trusteeship
* Clinically stable state Absence or recent infection within 3 months prior to inclusion Absence of progressive neoplasia No recent acute decompensation of chronic disease (thrust of heart failure, respiratory decompensated cirrhosis).
Absence of recent stroke
* musculoskeletal and neurological states of the lower limbs which allow the realization of the proposed functional tests.
* Patient has given written informed consent
* Absence of congenital or genetic degenerative muscle disease
Exclusion Criteria:
* Terminal chronic renal failure without replacement therapy
* Local anesthesic hypersensibility
* Corticosteroid treatment upper than 3 month
* COPD
* Oral anticoagulants
* Previous renal transplantation
* Subject not affiliated with a social security scheme, beneficiary or not such a plan
* Major subject protected by law or unable to consent under Article L 1121-8 of the Public Health Code
* Vulnerable person under Article L.1121-6 of the Public Health Code
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry