End Stage Renal DiseasePhase 2CLEARTOXNCT06595680
Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
A Phase 2 study testing Medialipide 20% perfusion, NaCl 0,9% and Blood sample in people with End Stage Renal Disease and Chronic Hemolysis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins (such as p-cresyl sulfate (p-CS) or indoxyl sulfate (IS)) due to their strong binding to serum albumin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Hemolysis
- What is being tested?
- Medialipide 20% perfusion, NaCl 0,9% and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 22 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- On haemodialysis at a frequency of 3 sessions of 4 hours per week, for at least 3 months.
- For patients of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) for the entire duration of treatment is required. A blood pregnancy test (beta-human chorionic gonadotropin (HCG)) will be carried out at inclusion.
- Patient affiliated to a social security scheme
- Free, informed and written consent signed by the patient
Who cannot join
- Residual diuresis > 100 mL per day
- Pregnant or breast-feeding
- Uncontrolled hypertension > 180/115 millimetre of mercury (mmHg)
- Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions
- Patients already on parenteral nutrition
- Patients already on Vitamin K antagonists (VKA) (or prescribed less than one month before inclusion)
Show all 24Show fewer
- Patients with allergy to heparin or requiring haemodialysis without anticoagulant (recent haemorrhage)
- Criteria relating to products/procedures: Patient with
- an allergy to egg, soya or peanut proteins or to one of the active ingredients or one of the excipients (glycerol, egg phospholipids for injection, a-tocopherol, sodium oleate (to adjust the pH), water for injection) of Médialipide
- Severe hyperlipidaemia or severe lipid metabolism disorder characterised by hypertriglyceridaemia > 3 mmol/l
- Sepsis < 1 month
- Severe liver failure or cholestasis
- Known severe coagulopathy
- Acute thrombo-embolic events
- Fat embolism
- Aggravating bleeding diathesis,
- Uncompensated metabolic acidosis.
- Unstable circulatory state threatening the vital prognosis (collapse and shock),
- Unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin),
- Acute phase of myocardial infarction or stroke,
- Uncorrected disturbances of fluid and electrolyte balance, such as hypokalaemia and hypotonic dehydration.
- Decompensated heart failure,
- Acute pulmonary oedema.
- Subject participating in another interventional study involving a drug with an exclusion period still in progress at inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Edouard Herriot
Lyon, 69003
Fitsum GUEBRE-EGZIABHER, PU,PH, 0472110260 ext. +33, fitsum.guebre-egziabher@chu-lyon.fr
Laure-Anne RAILLON, 0633345131 ext. +33, laure-anne.raillon@chu-lyon.fr
About this study
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins (such as p-cresyl sulfate (p-CS) or indoxyl sulfate (IS)) due to their strong binding to serum albumin. The accumulation of these toxins in end-stage renal failure patients on hemodialysis is strongly suspected to contribute to the significant morbidity and mortality observed in this population.
Pre-clinical studies conducted previously showed that medium-chain fatty acids (such as sodium octanoate and decanoate), which are natural ligands of albumin, can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session.
Read more
Medialipide® 20% (Braun) is an emulsion of medium chain triglycerides (MCT) (6 to 12 carbons) used in parenteral nutrition. Medialipide® constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94% of sodium octanoate and decanoate.
In this study, a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide® emulsion (as a sodium octanoate and decanoate donor) in patients during their hemodialysis session compared to a control situation Sodium chloride (NaCl) 0,9%).
- Conditions
- End Stage Renal Disease, Chronic Hemolysis
- Being tested
- Medialipide 20% perfusion, NaCl 0,9%, Blood sample
- Keywords
- End stage renal disease, Hemodialysis, Protein Bound Uremic Toxins, p-Cresyl Sulfate, Indoxyl Sulfate, Medium Chain fatty acids, Medium chain triglycerides, Octanoate, Decanoate, Medialipide
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medialipide 20% perfusionDrug
Each patient will receive during a 4 hours hemodialysis session a perfusion of Medialipide 20% at a rate of 0,11 g/kg/h. Medialipide will be perfused using the venous line connected to the hemodialysis machine.
NaCl 0,9%Drug
Each patient will receive during a 4 hours hemodialysis session a perfusion of NACL 0,9% with a volume corresponding to the one of Medialipide 20%. NaCl 0,9% will be perfused using the venous line connected to the hemodialysis machine.
Blood sampleBiological
Serial biological sampling for the measurement of different blood concentrations : electrolytes, serum protein , albumin, renal function (urea, creatinine), hemoglobin, hematocrit, liver test, lipid test, ketone bodies, 6 uremic toxins (including IS and p-CS), sodium octanoate and decanoate.
| Study group | Role | What they receive |
|---|---|---|
| Medialipide 20% - NaCl 0,9% | Experimental | Group 1 will receive during the first interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide also during 4 hours. Receives: Drug: Medialipide 20% perfusion; Drug: NaCl 0,9%; Biological: Blood sample |
| NaCl 0,9% - Medialipide 20% | Experimental | Group 2 will receive during the first interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) also during 4 hours. Receives: Drug: Medialipide 20% perfusion; Drug: NaCl 0,9%; Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialytic clearance of p-CS
Dialysis clearance of p-CS (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-CS in the dialysate, C arterial the concentration of p-CS in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Secondary outcomes (19)
Reduction fraction (RF) of p-CS
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of p-CS at T0 - Concentration of p-CS at T240)/Concentration of p-CS at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of Indoxyl sulfate
Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of Indoxyl sulfate in the dialysate, C arterial the concentration of Indoxyl sulfate in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of Indoxyl sulfate
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of Indoxyl sulfate at T0 - Concentration of Indoxyl sulfate at T240)/Concentration of Indoxyl sulfate at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of hippuric acid
Dialysis clearance of hippuric acid (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of hippuric acid in the dialysate, C arterial the concentration of hippuric acid in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of hippuric acid
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of hippuric acid at T0 - Concentration of hippuric acid at T240)/Concentration of hippuric acid at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of p-cresyl glucuronide
Dialysis clearance of p-cresyl glucuronide (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-cresyl glucuronide in the dialysate, C arterial the concentration of p-cresyl glucuronide in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of p-cresyl glucuronide
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of p-cresyl glucuronide at T0 - Concentration of p-cresyl glucuronide at T240)/Concentration of p-cresyl glucuronide at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of indol acetic acid
Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of indol acetic acid in the dialysate, C arterial the concentration of indol acetic acid in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of indol acetic acid
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of indol acetic acid at T0 - Concentration of indol acetic acid at T240)/Concentration of indol acetic acid at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of uric acid
Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of uric acid in the dialysate, C arterial the concentration of uric acid in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of uric acid
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of uric acid at T0 - Concentration of uric acid at T240)/Concentration of uric acid at T0
Measured: At 240 minutes after haemodialysis session
Dialytic clearance of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid
Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the dialysate, C arterial the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Reduction fraction (RF) of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid
Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation.
RF (%) = (Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0 - Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T240)/Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0
Measured: At 240 minutes after haemodialysis session
Tolerance of medialipide perfusion (%)
Percentage of patients with the occurrence of at least one symptom including: nausea, emesis, headaches during the hemodialysis session
Measured: until 240 minutes after haemodialysis session
Safety of medialipide perfusion
% of patients who presented one of the following event : hypertriglyceridemia > 4 gram/liter, alteration of liver test (cytolysis > 2 times the normal value, cholestasis > 2 times the normal value), or hemolysis.
Measured: until 7 days after the last haemodialysis session
octanoate blood concentration
Measured: until 240 minutes after haemodialysis session
decanoate blood concentration
Measured: until 240 minutes after haemodialysis session
clearance of octanoate
Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of octanoate in the dialysate, C arterial the concentration of octanoate in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
clearance of decanoate
Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows:
Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of decanoate in the dialysate, C arterial the concentration of decanoate in the blood sampled at the arterial port of the dialyser.
Measured: until 240 minutes after haemodialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will sequentially receive during two 4 hours hemodialysis session separated by one week a perfusion of Medialipide and a perfusion of NaCl 0,9%. The order of intervention will be determined by randomization.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595680
- Sponsor's protocol ID
- 69HCL23_0031
- Other IDs
- 2023-510406-41-00, 2023
- Acronym
- CLEARTOX
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
- ClinicalTrials.gov ID
- NCT06595680
- Acronym / sponsor ID
- CLEARTOX / 69HCL23_0031
- Conditions
- End Stage Renal Disease, Chronic Hemolysis
- Keywords
- End stage renal disease, Hemodialysis, Protein Bound Uremic Toxins, p-Cresyl Sulfate, Indoxyl Sulfate, Medium Chain fatty acids, Medium chain triglycerides, Octanoate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins (such as p-cresyl sulfate (p-CS) or indoxyl sulfate (IS)) due to their strong binding to serum albumin. The accumulation of these toxins in end-stage renal failure patients on hemodialysis is strongly suspected to contribute to the significant morbidity and mortality observed in this population.
Pre-clinical studies conducted previously showed that medium-chain fatty acids (such as sodium octanoate and decanoate), which are natural ligands of albumin, can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session.
Medialipide® 20% (Braun) is an emulsion of medium chain triglycerides (MCT) (6 to 12 carbons) used in parenteral nutrition. Medialipide® constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94% of sodium octanoate and decanoate.
In this study, a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide® emulsion (as a sodium octanoate and decanoate donor) in patients during their hemodialysis session compared to a control situation Sodium chloride (NaCl) 0,9%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient will sequentially receive during two 4 hours hemodialysis session separated by one week a perfusion of Medialipide and a perfusion of NaCl 0,9%. The order of intervention will be determined by randomization.
| Arm | Type | Receives |
|---|---|---|
| Medialipide 20% - NaCl 0,9% | Experimental | Drug: Medialipide 20% perfusion, Drug: NaCl 0,9%, Biological: Blood sampleGroup 1 will receive during the first interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide also during 4 hours. |
| NaCl 0,9% - Medialipide 20% | Experimental | Drug: Medialipide 20% perfusion, Drug: NaCl 0,9%, Biological: Blood sampleGroup 2 will receive during the first interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) also during 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- On haemodialysis at a frequency of 3 sessions of 4 hours per week, for at least 3 months.
- For patients of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) for the entire duration of treatment is required. A blood pregnancy test (beta-human chorionic gonadotropin (HCG)) will be carried out at inclusion.
- Patient affiliated to a social security scheme
- Free, informed and written consent signed by the patient
Key exclusion criteria (24 listed)
- Residual diuresis > 100 mL per day
- Pregnant or breast-feeding
- Uncontrolled hypertension > 180/115 millimetre of mercury (mmHg)
- Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions
- Patients already on parenteral nutrition
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 |
|---|---|---|
| Medialipide 20% perfusionEach patient will receive during a 4 hours hemodialysis session a perfusion of Medialipide 20% at a rate of 0,11 g/kg/h. Medialipide will be perfused using the venous line connected to the hemodialysis machine. | Drug | Medialipide 20% - NaCl 0,9%, NaCl 0,9% - Medialipide 20% |
| NaCl 0,9%Each patient will receive during a 4 hours hemodialysis session a perfusion of NACL 0,9% with a volume corresponding to the one of Medialipide 20%. NaCl 0,9% will be perfused using the venous line connected to the hemodialysis machine. | Drug | Medialipide 20% - NaCl 0,9%, NaCl 0,9% - Medialipide 20% |
| Blood sampleSerial biological sampling for the measurement of different blood concentrations : electrolytes, serum protein , albumin, renal function (urea, creatinine), hemoglobin, hematocrit, liver test, lipid test, ketone bodies, 6 uremic toxins (including IS and p-CS), sodium octanoate and decanoate. | Biological | Medialipide 20% - NaCl 0,9%, NaCl 0,9% - Medialipide 20% |
Primary outcome
Dialytic clearance of p-CS
Time frame: until 240 minutes after haemodialysis session
Dialysis clearance of p-CS (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-CS in the dialysate, C arterial the concentration of p-CS in the blood sampled at the arterial port of the dialyser.
19 secondary outcomes
Reduction fraction (RF) of p-CS
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of Indoxyl sulfate
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of Indoxyl sulfate
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of hippuric acid
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of hippuric acid
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of p-cresyl glucuronide
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of p-cresyl glucuronide
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of indol acetic acid
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of indol acetic acid
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of uric acid
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of uric acid
Time frame: At 240 minutes after haemodialysis session
Dialytic clearance of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid
Time frame: until 240 minutes after haemodialysis session
Reduction fraction (RF) of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid
Time frame: At 240 minutes after haemodialysis session
Tolerance of medialipide perfusion (%)
Time frame: until 240 minutes after haemodialysis session
Safety of medialipide perfusion
Time frame: until 7 days after the last haemodialysis session
octanoate blood concentration
Time frame: until 240 minutes after haemodialysis session
decanoate blood concentration
Time frame: until 240 minutes after haemodialysis session
clearance of octanoate
Time frame: until 240 minutes after haemodialysis session
clearance of decanoate
Time frame: until 240 minutes after haemodialysis session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medialipide 20% perfusion, NaCl 0,9% and Blood sample in people with End Stage Renal Disease and Chronic Hemolysis, run by Hospices Civils de Lyon 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 5 inclusion and 24 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: opening soon, as of the sponsor's last update on 19 Sep 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fitsum GUEBRE EGZIABHER, PU,PH (0472110260 ext. +33, fitsum.guebre-egziabher@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialytic clearance of p-CS (time frame: until 240 minutes after haemodialysis session). 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 19 Sep 2024.