A Phase 2 interventional study of Medialipide 20% perfusion and NaCl 0,9% in End Stage Renal Disease and Chronic Hemolysis, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Treatment
Among 145 studies in Kidney Failure, Chronic with a site in France — 28 open to participants now, 33 under way, 6 of them phase 3. Kidney Failure, Chronic · France.
Among the 145 studies in Kidney Failure, Chronic with a site in France, this one is the 93rd largest by planned enrollment of the 105 interventional ones that give a count, is one of 4 that started in 2025, is one of 12 in phase 2, reaches primary completion later than 13 of the 32 other live ones, and was the 138th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →28 of the 145 studies in Kidney Failure, Chronic with a site in France are open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
University of Avignon · Sites in France
University Hospital, Strasbourg, France · Sites in France
Centre Hospitalier Régional d'Orléans · Sites in France
Hospices Civils de Lyon · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 16 · Phase 3 26 · Phase 4 9
First in 1994; this study’s year is marked. 4 started in 2025.
This study's planned enrollment of 12 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 70 across the 105 interventional studies, 177 across the 40 observational. Of the 90 that completed or were terminated, 15 (17%) have results posted.
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39 of 145 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 8 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
8 of the studies in Kidney Failure, Chronic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05562869Phase 3Nantes University HospitalBelatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction | 2027-05-03 |
| NCT06692231Centre Hospitalier de VichyImpact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients | 2026-11-30 |
| NCT06474169Centre Hospitalier Régional d'OrléansAssessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients. | 2026-12 |
| NCT06595680Hospices Civils de LyonDevelopment of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins | 2027-01-22 |
| NCT06887075University Hospital, BordeauxSystemic Activation of Inflammasomes and Frailty in Older Candidates to Kidney Transplantation | 2027-02-15 |
Among the 145 studies in Kidney Failure, Chronic with a site in France, from their registry updates:
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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%).
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Exclusion Criteria:
Criteria relating to products/procedures: Patient with
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Medialipide 20% perfusion · Drug: NaCl 0,9% · Biological: Blood sample
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.
Drug: Medialipide 20% perfusion · Drug: NaCl 0,9% · Biological: Blood sample
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.
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.
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.
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.
Time frame: until 240 minutes after haemodialysis session
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
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
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.
Time frame: 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.
Time frame: until 240 minutes after haemodialysis session
Start is estimated for Jan 2025; primary completion for Jan 2027, 24 months later.
Of 41 non-industry phase 2 interventional studies under Kidney Failure, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's planned 24 months is below that.
Counting every sponsor, half of 67 studies reached it within 32 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Chloride