Acute Kidney InjuryCompEERNCT06369064
Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient
A study testing CVVHD Dialysis parameters and CVVHDF Dialysis parameters in people with Acute Kidney Injury and Continuous Renal Replacement Therapy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Continuous Renal Replacement Therapy, Intensive Care Unit
- What is being tested?
- CVVHD Dialysis parameters and CVVHDF Dialysis parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2024to 15 Aug 2028
- Phase
- Interventional
- 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
- Adult patients hospitalized in ICU
- Undergo RRT session because of AKI stage 3
- At least one among criteria: pH < 7,20 / Blood urea > 30mM / Fluid overload uncontrolled by with PaCO₂ < 35 mmHg or mixed acidosis with PaCO₂ < 50 mmHg.
- Oliguria lasting 72 hours or longer
- Patients undergoing their first session of extracorporeal blood purification, initiated less than 12 hours prior to randomization
- Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation
- Patient affiliated with Social Security.
Who cannot join
- End-stage chronic kidney disease on dialysis
- Intoxication with a dialyzable toxin (lithium
- Criteria for emergency dialysis initiation: hyperkaliemia >6,5mM with electrocardiographic signs
- Medical contraindication to regional citrate: severe liver failure
- Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding
- Pregnant women, parturient or breast-feeding patient
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, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes, 30029
Claire Roger, MD, PhD, claire.roger@chu-nimes.fr
Claire Roger, MD, PhD
About this study
Official title: Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury : a Monocentric Controled Randomized Non Inferiority Open Labeled Study
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
Read more
In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT.
Read the detailed description
Acute Kidney Injury (AKI) is found in more than 50% of intensive care unit (ICU) patients, with 30% classified as AKI Network (AKIN) stage 3. Approximately 23% of AKI patients undergo RRT, predominantly utilizing continuous techniques due to better hemodynamic tolerance in unstable patients. Common continuous RRT techniques include continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF).
The two most employed techniques in ICU are CVVHDF and CVVHD. However, the choice often depends on institutional practices rather than scientific evidence. Limited studies comparing these techniques at equivalent doses exist, and French recommendations allow intensivists discretion based on availability and team experience. A small, randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance. Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences.
Despite potential benefits of CVVHD with citrate, such as extended filter lifespan and stable dialysis dose, the impact on concomitant treatments, especially antibiotics, needs consideration.
The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis (CVVHD) compared to heparin-based continuous hemodiafiltration (CVVHDF) in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy.
The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin, providing prolonged and stable clearance, facilitating antibiotic management during RRT.
- Being tested
- CVVHD Dialysis parameters, CVVHDF Dialysis parameters
- Keywords
- continuous venovenous hemodiafiltration, continuous venovenous hemodialysis, urea reduction rate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVHD Dialysis parametersOther
Patients will receive a CVVHD dialysis with a dose of 25ml/kg/h dialysate (100% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²).Regional anticoagulation with citrate
CVVHDF Dialysis parametersOther
Patients will receive a CVVHDF dialysis with a dose of 25ml/kg/h dialysate (50% ultrafiltration, 50% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²). Systemic anticoagulation with heparine
| Study group | Role | What they receive |
|---|---|---|
| CVVHD | Experimental | Patient requiring renal remplacement therapy treated with by continuous venovenous hemodialysis (CVVHD) method. Receives: Other: CVVHD Dialysis parameters |
| CVVHDF | Active comparator | Patient requiring renal remplacement therapy treated with by continuous venovenous hemodiafiltration (CVVHDF) method. Receives: Other: CVVHDF Dialysis parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
urea reduction rate (URR)
The primary endpoint is the rate of urea reduction (TRU) at 24h as a percentage TRU H24 = (urea rate at H0 - urea rate at H24) / urea rate at H0 in each arm.
Measured: 24 hours
Secondary outcomes (11)
Creatinine clearance at H24
Measured Creatinine clearance at 24 hours (ml/min)
Measured: 24 hours
Urea clearance at H24
Measured Urea clearance at 24 hours (ml/min)
Measured: 24 hours
Urea clearance at H48
Measured Urea clearance at 48 hours (ml/min)
Measured: 48 hours
ICU Mortality
Number of patients who died while in ICU
Measured: End of ICU Stay
Mortality at Day 28
Number of patients who died betwwen day à and day 28
Measured: Day 28
Organ failure-free days at Day 28
Number of organ failure-free days at Day 28
Measured: Day 28
Hypokalemia at Day 28
Hypokalemia < 3mmol/l occurring between Day 0 and Day 28
Measured: Day 28
Hypophosphatemia at Day 28
Hypophosphatemia < 0.8mmol/l occurring between Day 0 and Day 28
Measured: Day 28
Hypomagnesemia at Day 28
Hypomagnesemia < 0.8mmol/l occurring between Day 0 and Day 28
Measured: Day 28
Hyperkalemia at Day 28
Hyperkalemia >6mmol/l occurring between Day 0 and Day 28
Measured: Day 28
Medical Cost
Cost of one continuous hemodialysis (CVVHD) session with citrate compared to one continuous hemodiafiltration (CVVHDF)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 Jul 2024
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369064
- Sponsor's protocol ID
- 2023A02707-38
- Acronym
- CompEER
- Status last verified
- May 2026
- First submitted
- 12 Apr 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Joannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.
PubMed 23740278Vinsonneau C, Allain-Launay E, Blayau C, Darmon M, Ducheyron D, Gaillot T, Honore PM, Javouhey E, Krummel T, Lahoche A, Letacon S, Legrand M, Monchi M, Ridel C, Robert R, Schortgen F, Souweine B, Vaillant P, Velly L, Osman D, Van Vong L. Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD). Ann Intensive Care. 2015 Dec;5(1):58. doi: 10.1186/s13613-015-0093-5. Epub 2015 Dec 30.
PubMed 26714808Guilhaumou R, Benaboud S, Bennis Y, Dahyot-Fizelier C, Dailly E, Gandia P, Goutelle S, Lefeuvre S, Mongardon N, Roger C, Scala-Bertola J, Lemaitre F, Garnier M. Optimization of the treatment with beta-lactam antibiotics in critically ill patients-guidelines from the French Society of Pharmacology and Therapeutics (Societe Francaise de Pharmacologie et Therapeutique-SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Societe Francaise d'Anesthesie et Reanimation-SFAR). Crit Care. 2019 Mar 29;23(1):104. doi: 10.1186/s13054-019-2378-9.
PubMed 30925922Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.
PubMed 33095849
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury : a Monocentric Controled Randomized Non Inferiority Open Labeled Study
- ClinicalTrials.gov ID
- NCT06369064
- Acronym / sponsor ID
- CompEER / 2023A02707-38
- Keywords
- continuous venovenous hemodiafiltration, continuous venovenous hemodialysis, urea reduction rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 16 Apr 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.
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT.
Detailed description
Acute Kidney Injury (AKI) is found in more than 50% of intensive care unit (ICU) patients, with 30% classified as AKI Network (AKIN) stage 3. Approximately 23% of AKI patients undergo RRT, predominantly utilizing continuous techniques due to better hemodynamic tolerance in unstable patients. Common continuous RRT techniques include continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF).
The two most employed techniques in ICU are CVVHDF and CVVHD. However, the choice often depends on institutional practices rather than scientific evidence. Limited studies comparing these techniques at equivalent doses exist, and French recommendations allow intensivists discretion based on availability and team experience. A small, randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance. Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences.
Despite potential benefits of CVVHD with citrate, such as extended filter lifespan and stable dialysis dose, the impact on concomitant treatments, especially antibiotics, needs consideration.
The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis (CVVHD) compared to heparin-based continuous hemodiafiltration (CVVHDF) in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy.
The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin, providing prolonged and stable clearance, facilitating antibiotic management during RRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVHD | Experimental | Other: CVVHD Dialysis parametersPatient requiring renal remplacement therapy treated with by continuous venovenous hemodialysis (CVVHD) method. |
| CVVHDF | Active comparator | Other: CVVHDF Dialysis parametersPatient requiring renal remplacement therapy treated with by continuous venovenous hemodiafiltration (CVVHDF) method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients hospitalized in ICU
- Undergo RRT session because of AKI stage 3
- At least one among criteria: pH < 7,20 / Blood urea > 30mM / Fluid overload uncontrolled by with PaCO₂ < 35 mmHg or mixed acidosis with PaCO₂ < 50 mmHg.
- Patients undergoing their first session of extracorporeal blood purification, initiated less than 12 hours prior to randomization
- Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation
Key exclusion criteria (6 listed)
- End-stage chronic kidney disease on dialysis
- Intoxication with a dialyzable toxin (lithium
- Criteria for emergency dialysis initiation: hyperkaliemia >6,5mM with electrocardiographic signs
- Medical contraindication to regional citrate: severe liver failure
- Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding
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 |
|---|---|---|
| CVVHD Dialysis parametersPatients will receive a CVVHD dialysis with a dose of 25ml/kg/h dialysate (100% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²).Regional anticoagulation with citrate | Other | CVVHD |
| CVVHDF Dialysis parametersPatients will receive a CVVHDF dialysis with a dose of 25ml/kg/h dialysate (50% ultrafiltration, 50% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²). Systemic anticoagulation with heparine | Other | CVVHDF |
Primary outcome
urea reduction rate (URR)
Time frame: 24 hours
The primary endpoint is the rate of urea reduction (TRU) at 24h as a percentage TRU H24 = (urea rate at H0 - urea rate at H24) / urea rate at H0 in each arm.
11 secondary outcomes
Creatinine clearance at H24
Time frame: 24 hours
Urea clearance at H24
Time frame: 24 hours
Urea clearance at H48
Time frame: 48 hours
ICU Mortality
Time frame: End of ICU Stay
Mortality at Day 28
Time frame: Day 28
Organ failure-free days at Day 28
Time frame: Day 28
Hypokalemia at Day 28
Time frame: Day 28
Hypophosphatemia at Day 28
Time frame: Day 28
Hypomagnesemia at Day 28
Time frame: Day 28
Hyperkalemia at Day 28
Time frame: Day 28
Medical Cost
Time frame: 24 hours
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 18 May 2026.
- Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 23740278Joannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.
- Background: PubMed 26714808Vinsonneau C, Allain-Launay E, Blayau C, Darmon M, Ducheyron D, Gaillot T, Honore PM, Javouhey E, Krummel T, Lahoche A, Letacon S, Legrand M, Monchi M, Ridel C, Robert R, Schortgen F, Souweine B, Vaillant P, Velly L, Osman D, Van Vong L. Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD). Ann Intensive Care. 2015 Dec;5(1):58. doi: 10.1186/s13613-015-0093-5. Epub 2015 Dec 30.
- Background: PubMed 30925922Guilhaumou R, Benaboud S, Bennis Y, Dahyot-Fizelier C, Dailly E, Gandia P, Goutelle S, Lefeuvre S, Mongardon N, Roger C, Scala-Bertola J, Lemaitre F, Garnier M. Optimization of the treatment with beta-lactam antibiotics in critically ill patients-guidelines from the French Society of Pharmacology and Therapeutics (Societe Francaise de Pharmacologie et Therapeutique-SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Societe Francaise d'Anesthesie et Reanimation-SFAR). Crit Care. 2019 Mar 29;23(1):104. doi: 10.1186/s13054-019-2378-9.
- Background: PubMed 33095849Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.
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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.
Claire Roger principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVVHD Dialysis parameters and CVVHDF Dialysis parameters in people with Acute Kidney Injury and Continuous Renal Replacement Therapy, run by Centre Hospitalier Universitaire de Nīmes 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
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 Claire Roger, MD (04.66.68.30.50, Claire.roger@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urea reduction rate (URR) (time frame: 24 hours). 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 NCT06369064, which also lists 5 linked publications.
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 18 May 2026.