Chronic Renal Failure Requiring HemodialysisPOPEYENCT02794142
Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient
A study testing renal transplantation in people with Chronic Renal Failure Requiring Hemodialysis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure Requiring Hemodialysis
- What is being tested?
- renal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Mar 2018
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Terminal chronic renal failure without replacement therapy
- Local anesthesic hypersensibility
- Corticosteroid treatment upper than 3 month
- COPD
- Oral anticoagulants
- Previous renal transplantation
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient
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.
- Being tested
- renal transplantation, No intervention
- Keywords
- hemodialysis, muscle dysfunction, mitochondria, oxidative stress, inflammation, renal transplantation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal transplantationProcedure or surgery
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| HD patient | Experimental | Not described Receives: Procedure: renal transplantation |
| Healthy volunteers | Other | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry
Measured: 2 years
Secondary outcomes (1)
Maximum voluntary contraction of the quadriceps (in Newton.meter)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal Failure Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794142
- Sponsor's protocol ID
- 9459-2
- Acronym
- POPEYE
- Status last verified
- Jan 2021
- First submitted
- 26 May 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.
PubMed 34750160
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient
- ClinicalTrials.gov ID
- NCT02794142
- Acronym / sponsor ID
- POPEYE / 9459-2
- Keywords
- hemodialysis, muscle dysfunction, mitochondria, oxidative stress, inflammation, renal transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Jun 2016 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD patient | Experimental | Procedure: renal transplantation |
| Healthy volunteers | Other | Other: No intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- Terminal chronic renal failure without replacement therapy
- Local anesthesic hypersensibility
- Corticosteroid treatment upper than 3 month
- COPD
- Oral anticoagulants
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 |
|---|---|---|
| renal transplantation | Procedure or surgery | HD patient |
| No intervention | Other | Healthy volunteers |
Primary outcome
Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry
Time frame: 2 years
1 secondary outcome
Maximum voluntary contraction of the quadriceps (in Newton.meter)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 34750160Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.
Related trials for Chronic Renal Failure Requiring Hemodialysis
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Not yet recruitingObservational study
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Coronary Artery Calcification, Cardiovascular Risk
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Active, not recruiting
DisTal Arterio-Venous Fistula Feasibility
End-Stage Renal Disease Requiring Haemodialysis
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 study testing renal transplantation in people with Chronic Renal Failure Requiring Hemodialysis, run by University Hospital, Montpellier at 1 site in France.
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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Feb 2021. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794142, which also lists 1 linked publication.
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 3 Feb 2021.