Acute Kidney InjuryPhase 2NCT07052513
Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
A Phase 2 study testing M2RLAB 001 in people with Acute Kidney Injury, run by M2RLAB SL at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- M2RLAB 001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 14 Dec 2025to 2 Sep 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
- Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.
- Participants must meet one of the following two criteria:
- Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale, in case the participants had signed the IC before.
- Participants that had signed the IC within 12 hours after the AKI diagnosis.
- Present AKI within the first 48 hours post cardiac surgery in one of the following classifications defined by the AKIN scale (Acute Kidney Injury Network):
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- AKIN 1: An increase in serum creatinine by at least 0.3 mg/dL (more or equal to 26.4 micromol/L) from baseline, or an increase to more or equal to 150-200 percent (corresponding to a 1.5- to 2-fold increase) from baseline. In addition, the participant must have a positive acute tubular necrosis score within the first 48 hours post cardiac surgery, defined as the presence of at least 3 of the following 4 scenarios: Sodium excretion fraction more than 2 percent, urinary osmolality lower than 400 mOsm/kg, urine sodium more than 40 mmol/L, presence of shock or nephrotoxic agents.
- AKIN 2: An increase in serum creatinine to more than 200 percent and up to a maximum of 300 percent (corresponding to an increase of more than 2 and up to 3 times) over baseline.
- AKIN 3: An increase in serum creatinine to more than 300 percent (corresponding to more than 3-fold increase) over baseline, or an increase in serum creatinine levels to more or equal to 4.0 mg/dl (more or equal to 354 micromol/l) with an acute increase of at least 0.5 mg/dl (44 micromol/l).
- In the case of women or men of childbearing age, for safety, those who undertake to follow the contraceptive measures required from their discharge from hospital until the end of their participation in the clinical trial.
Who cannot join
- Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate [GFR] less than 30 ml/min).
- AKI one month prior to heart surgery.
- Participants who have previously undergone renal replacement therapy.
- Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start renal replacement therapy within the next 48 hours after AKI diagnosis.
- Interstitial glomerulonephritis or vasculitis.
- Pregnancy.
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- Women in breastfeeding period
- Renal transplant history.
- Endocarditis.
- Participants with mechanical assistance devices: extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
- Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] less than 30 percent).
- Post-surgical septic infectious condition.
- Clinically significant anemia with hemoglobin values below 100g/l.
- Positive serology for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: Rapid Plasma Reagin). This criterion will be assessed once it has been confirmed that the participant has developed AKI.
- Participants enrolled in another clinical trial testing.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery.
The main questions it aims to answer are:
- Does cell therapy reduce the recovery time of kidney function?
- What medical problems do participants have when receiving cell therapy?
Researchers will compare cell therapy with a placebo (a look-alike substance that contains no drug) to see if cell therapy works to treat AKI. The safety of cell therapy with leukocyte cells will also be studied.
Read the detailed description
This is a Phase II, multi-center, randomized, placebo-controlled clinical trial, with 2 treatment arms and single blind. After being informed about the study, participants who meet the eligibility criteria will be randomized in 1:1 ratio to treatment with a single administration of cell therapy with leukocyte cells from the participant himself/herself or placebo (approximately 49 subjects per group).
Acute kidney injury (AKI) is one of the main complications after cardiac surgery. In fact, AKI after cardiac surgery is associated with high morbidity and mortality. Currently, there are no effective therapies for kidney injury after cardiac surgery, but there is evidence that recovery is possible if the injury processes are overcome. Thus, due to the lack of preventive and therapeutic options at present, cell therapy has gained importance in recent years in different clinical trials. Thus, within this context, the use of modified leukocyte cells as cell therapy is also an alternative for the treatment of AKI due to their powerful immunomodulatory effect. On the other hand, the use of placebo is justified because there is currently no other pharmacological treatment available to serve as an active control. A placebo-controlled study is optimal to evaluate the efficacy and safety of an experimental treatment.
Researchers hypothesized that cell therapy with autologous leukocyte cells can be safe, well tolerated and clinically beneficial versus placebo for participants who develop AKI within the first 48 hours after cardiac surgery.
This study consists of 3 phases: the initial phase, the observation phase, and the follow-up phase. The total duration of each participant in the trial will be from 3 to 5 months:
- Initial phase: It starts when the participant signs the informed consent (IC) and it lasts until he or she receives the investigational drug/placebo. There are two possible scenarios: The participants undergoing cardiac surgery can sign the informed consent (IC) before the surgery (at a scheduled visit prior to his/her hospitalization or at the time of his/her hospitalization and prior to undergoing the procedure) or, alternatively, they can sign the informed consent (IC) after the surgery and the development of AKI within 48 hours. As indicated in the Inclusion criteria, only participants who present AKI within the first 48 hours post cardiac surgery will be included. The participants who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two study groups. A volume of at least 60 mL of peripheral blood will be extracted from the participant, from which the cell therapy will be prepared (in cases where the participant is included in the experimental group) The investigational product/placebo will be administered to the participant within 48 hours of AKI diagnosis.
- Observation phase: It includes the period from when the participant receives the investigational drug/placebo until he or she is discharged from the hospital. This period lasts 16 to 20 days, depending on the clinical evolution of the participants. During this phase, participants will be followed and will undergo different tests to evaluate the effectiveness and safety of the investigational treatment vs. placebo.
- Follow-up phase: It includes the period from when the participant receives hospital discharge and ends 90 days from the date of inclusion of the participant in the study. At this stage, participants will be monitored to evaluate the efficacy and safety of the experimental cell therapy drug vs. placebo.
Besides, if the participants give their consent, blood and urine samples will be collected to perform a metabolomic sub-study. The main objective is to identify biomarkers of efficacy of the treatment with M2RLAB 001.
- Conditions
- Acute Kidney Injury
- Being tested
- Placebo, M2RLAB 001
- Keywords
- Cardiac Surgery, Thoracic Surgery, Acute Renal Insufficiency, Acute Renal Injury, Major Adverse Kidney Event, Autologous Leukocyte Cells, Leukocyte Cells, Autologous Mononuclear Cells, Mononuclear Cells, Acute Kidney Disease
- 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.
PlaceboDrug
Also called Saline Solution
Intravenous infusion of normal saline.
M2RLAB 001Drug
Also called Autologous Leukocyte Cells
Intravenous infusion of M2RLAB 001
| Study group | Role | What they receive |
|---|---|---|
| Saline Solution for injection | Placebo comparator | Participants randomized to placebo will receive a single 10 mL dose Intravenous (IV) infusion of normal saline (0.9 percent) no later than 48 hours after the participant's diagnosis of AKI. Receives: Drug: Placebo |
| Cell therapy with leukocyte cells from the participant himself/herself | Experimental | Participants randomized to experimental group will receive a single 10 mL dose IV of leukocyte cells concentration of 6-15.4 x10^6 cells/mL no later than 48 hours after the participant's diagnosis of AKI. Receives: Drug: M2RLAB 001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time of kidney function
Time (in days) to recovery of the creatinine to baseline values (in the range of more or less than 30 percent from baseline).
Measured: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Proportion of participants with persistently altered creatinine values (more than 31 percent from baseline values) 7 days after AKI episode
Measured as the incidence of Acute Kidney Disease (AKD): persistence of altered creatinine values 7 days after the AKI episode.
Measured: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment
Occurrence of adverse events (AEs)
Number of AEs reported.
Measured: Up to Day 90
Occurrence of serious AEs (SAEs)
Number of SAEs reported
Measured: Up to Day 90
Occurrence of AEs resulting in discontinuation of study treatment
Number of AEs resulting in discontinuation of study treatment reported
Measured: Up to Day 90
Occurrence of AEs of special interest (AESIs)
Number of AESIs reported.
Measured: Up to Day 90
Secondary outcomes (18)
Major Adverse Kidney Events (MAKE) incidence reduction
Proportion of participants with MAKE incidence reduction. MAKE is considered as the development of events related to disease progression, which is defined as death related to renal failure, need for dialysis or permanent reduction of estimated Glomerular Filtration Rate more than 30 percent since baseline
Measured: Baseline Phase: Day 0, Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment) and Follow-up phase: Day 30 and 90
Time to appear of Major Adverse Kidney Events (MAKE)
Time to appear of MAKE. MAKE is considered as the development of events related to disease progression, which is defined as death related to renal failure, need for dialysis or permanent reduction of estimated Glomerular Filtration Rate more than 30 percent since baseline
Measured: Up to Day 90
Number of participants on renal replacement therapy
Number of participants requiring dialysis
Measured: Up to Day 90
Renal replacement therapy duration.
Time (in days) of the required dialysis.
Measured: Up to Day 90
Duration of admission to Intensive Care Unit (ICU)
Time (in days) of ICU stay of participants.
Measured: Up to Day 90
Duration of hospital stay
Time (in days) of hospital stay of participants.
Measured: Up to Day 90
Patient survival after 30 days
Proportion of participants who survived after 30 days.
Measured: Up to Day 30
Patient survival after 90 days
Proportion of participants who survived after 90 days.
Measured: Up to Day 90
Participants requiring dialysis versus participants who survived without requiring dialysis after 30 days
Proportion of participants who survived requiring dialysis versus participants who survived without requiring dialysis after 30 days post cardiac surgery.
Measured: Up to Day 30
Participants requiring dialysis versus participants who survived without requiring dialysis after 90 days
Proportion of participants who survived requiring dialysis versus participants who survived without requiring dialysis after 90 days post cardiac surgery.
Measured: Up to Day 90
Maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Maximum creatinine value (peak creatinine) recorded. Creatinine levels will be measured in serum.
Measured: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Time (day) of maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Day of maximum creatinine values (peak creatinine) recorded. Creatinine levels will be measured in serum.
Measured: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Improvement in levels of injury biomarkers in urine
Proportion of participants with variations of more than 30 percent in the values of injury biomarkers in urine [Albumin and Neutrophil gelatinase-associated lipocalin (NGAL)]
Measured: Baseline Phase: Day 0 and Observation Phase: Visit 7 (7 days after treatment)
Participants presenting surgical wound infections
Proportion of participants with surgical wound infections.
Measured: Up to Day 90
Participants presenting respiratory infections during ICU stay
Proportion of participants with respiratory infections during ICU stay.
Measured: Up to Day 90
Participants who present complications related to surgery
Proportion of participants with any complication related to surgery (Sternotomy, Reintervention, Circulatory support).
Measured: Up to Day 90
Number of complications related to surgery
Absolute number of any complication related to surgery (Sternotomy, Reintervention, Circulatory support).
Measured: Up to Day 90
Unexplained haemodynamic worsening
Unexplained haemodynamic worsening measured as: drop in cardiac index to less than 2.5 L/min/m^2 (if it was previously higher), drop in systemic systolic blood pressure more than 30 percent or to less than 90 mmgHg, and/or more than 30 increase in vasoactive drugs dose.
Measured: Observational Phase: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start14 Dec 2025
- Primary completion17 Jun 2028 (estimated)
- Study completion2 Sep 2028 (estimated)
Why it stopped: Insufficient resources to continue the study at this time (including financial and operational constraints).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M2RLAB SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esteban Poch López de Briñas, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052513
- Sponsor's protocol ID
- M2R.AKI.2021
- Other IDs
- 2023-504610-30-01, 2023
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jativa S, Torrico S, Calle P, Munoz A, Garcia M, Larque AB, Poch E, Hotter G. NGAL release from peripheral blood mononuclear cells protects against acute kidney injury and prevents AKI induced fibrosis. Biomed Pharmacother. 2022 Sep;153:113415. doi: 10.1016/j.biopha.2022.113415. Epub 2022 Jul 18.
PubMed 36076483Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07052513
- Acronym / sponsor ID
- M2R.AKI.2021
- Conditions
- Acute Kidney Injury
- Keywords
- Cardiac Surgery, Thoracic Surgery, Acute Renal Insufficiency, Acute Renal Injury, Major Adverse Kidney Event, Autologous Leukocyte Cells, Leukocyte Cells, Autologous Mononuclear Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Insufficient resources to continue the study at this time (including financial and operational constraints).
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- M2RLAB SLIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- 17 Jun 2028 (estimated)
- Study completion
- 2 Sep 2028 (estimated)
- First posted
- 4 Jul 2025 (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.
The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery.
The main questions it aims to answer are:
- Does cell therapy reduce the recovery time of kidney function?
- What medical problems do participants have when receiving cell therapy?
Researchers will compare cell therapy with a placebo (a look-alike substance that contains no drug) to see if cell therapy works to treat AKI. The safety of cell therapy with leukocyte cells will also be studied.
Detailed description
This is a Phase II, multi-center, randomized, placebo-controlled clinical trial, with 2 treatment arms and single blind. After being informed about the study, participants who meet the eligibility criteria will be randomized in 1:1 ratio to treatment with a single administration of cell therapy with leukocyte cells from the participant himself/herself or placebo (approximately 49 subjects per group).
Acute kidney injury (AKI) is one of the main complications after cardiac surgery. In fact, AKI after cardiac surgery is associated with high morbidity and mortality. Currently, there are no effective therapies for kidney injury after cardiac surgery, but there is evidence that recovery is possible if the injury processes are overcome. Thus, due to the lack of preventive and therapeutic options at present, cell therapy has gained importance in recent years in different clinical trials. Thus, within this context, the use of modified leukocyte cells as cell therapy is also an alternative for the treatment of AKI due to their powerful immunomodulatory effect. On the other hand, the use of placebo is justified because there is currently no other pharmacological treatment available to serve as an active control. A placebo-controlled study is optimal to evaluate the efficacy and safety of an experimental treatment.
Researchers hypothesized that cell therapy with autologous leukocyte cells can be safe, well tolerated and clinically beneficial versus placebo for participants who develop AKI within the first 48 hours after cardiac surgery.
This study consists of 3 phases: the initial phase, the observation phase, and the follow-up phase. The total duration of each participant in the trial will be from 3 to 5 months:
- Initial phase: It starts when the participant signs the informed consent (IC) and it lasts until he or she receives the investigational drug/placebo. There are two possible scenarios: The participants undergoing cardiac surgery can sign the informed consent (IC) before the surgery (at a scheduled visit prior to his/her hospitalization or at the time of his/her hospitalization and prior to undergoing the procedure) or, alternatively, they can sign the informed consent (IC) after the surgery and the development of AKI within 48 hours. As indicated in the Inclusion criteria, only participants who present AKI within the first 48 hours post cardiac surgery will be included. The participants who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two study groups. A volume of at least 60 mL of peripheral blood will be extracted from the participant, from which the cell therapy will be prepared (in cases where the participant is included in the experimental group) The investigational product/placebo will be administered to the participant within 48 hours of AKI diagnosis.
- Observation phase: It includes the period from when the participant receives the investigational drug/placebo until he or she is discharged from the hospital. This period lasts 16 to 20 days, depending on the clinical evolution of the participants. During this phase, participants will be followed and will undergo different tests to evaluate the effectiveness and safety of the investigational treatment vs. placebo.
- Follow-up phase: It includes the period from when the participant receives hospital discharge and ends 90 days from the date of inclusion of the participant in the study. At this stage, participants will be monitored to evaluate the efficacy and safety of the experimental cell therapy drug vs. placebo.
Besides, if the participants give their consent, blood and urine samples will be collected to perform a metabolomic sub-study. The main objective is to identify biomarkers of efficacy of the treatment with M2RLAB 001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Solution for injection | Placebo comparator | Drug: PlaceboParticipants randomized to placebo will receive a single 10 mL dose Intravenous (IV) infusion of normal saline (0.9 percent) no later than 48 hours after the participant's diagnosis of AKI. |
| Cell therapy with leukocyte cells from the participant himself/herself | Experimental | Drug: M2RLAB 001Participants randomized to experimental group will receive a single 10 mL dose IV of leukocyte cells concentration of 6-15.4 x10^6 cells/mL no later than 48 hours after the participant's diagnosis of AKI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
- Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.
- Participants must meet one of the following two criteria:
- Present AKI within the first 48 hours post cardiac surgery in one of the following classifications defined by the AKIN scale (Acute Kidney Injury Network):
- AKIN 1: An increase in serum creatinine by at least 0.3 mg/dL (more or equal to 26.4 micromol/L) from baseline, or an increase to more or equal to 150-200 percent (corresponding to a 1.5- to 2-fold increase) from baseline. In addition, the participant must have a positive acute tubular necrosis score within the first 48 hours post cardiac surgery, defined as the presence of at least 3 of the following 4 scenarios: Sodium excretion fraction more than 2 percent, urinary osmolality lower than 400 mOsm/kg, urine sodium more than 40 mmol/L, presence of shock or nephrotoxic agents.
Key exclusion criteria (15 listed)
- Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate [GFR] less than 30 ml/min).
- AKI one month prior to heart surgery.
- Participants who have previously undergone renal replacement therapy.
- Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start renal replacement therapy within the next 48 hours after AKI diagnosis.
- Interstitial glomerulonephritis or vasculitis.
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 |
|---|---|---|
| PlaceboAlso: Saline SolutionIntravenous infusion of normal saline. | Drug | Saline Solution for injection |
| M2RLAB 001Also: Autologous Leukocyte CellsIntravenous infusion of M2RLAB 001 | Drug | Cell therapy with leukocyte cells from the participant himself/herself |
Primary outcome
Recovery time of kidney function
Time frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Time (in days) to recovery of the creatinine to baseline values (in the range of more or less than 30 percent from baseline).
Proportion of participants with persistently altered creatinine values (more than 31 percent from baseline values) 7 days after AKI episode
Time frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment
Measured as the incidence of Acute Kidney Disease (AKD): persistence of altered creatinine values 7 days after the AKI episode.
Occurrence of adverse events (AEs)
Time frame: Up to Day 90
Number of AEs reported.
Occurrence of serious AEs (SAEs)
Time frame: Up to Day 90
Number of SAEs reported
Occurrence of AEs resulting in discontinuation of study treatment
Time frame: Up to Day 90
Number of AEs resulting in discontinuation of study treatment reported
Occurrence of AEs of special interest (AESIs)
Time frame: Up to Day 90
Number of AESIs reported.
18 secondary outcomes
Major Adverse Kidney Events (MAKE) incidence reduction
Time frame: Baseline Phase: Day 0, Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment) and Follow-up phase: Day 30 and 90
Time to appear of Major Adverse Kidney Events (MAKE)
Time frame: Up to Day 90
Number of participants on renal replacement therapy
Time frame: Up to Day 90
Renal replacement therapy duration.
Time frame: Up to Day 90
Duration of admission to Intensive Care Unit (ICU)
Time frame: Up to Day 90
Duration of hospital stay
Time frame: Up to Day 90
Patient survival after 30 days
Time frame: Up to Day 30
Patient survival after 90 days
Time frame: Up to Day 90
Participants requiring dialysis versus participants who survived without requiring dialysis after 30 days
Time frame: Up to Day 30
Participants requiring dialysis versus participants who survived without requiring dialysis after 90 days
Time frame: Up to Day 90
Maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Time frame: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Time (day) of maximum creatinine values (peak creatinine) recorded during participants' hospitalization
Time frame: Baseline Phase: Day 0 and Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
Improvement in levels of injury biomarkers in urine
Time frame: Baseline Phase: Day 0 and Observation Phase: Visit 7 (7 days after treatment)
Participants presenting surgical wound infections
Time frame: Up to Day 90
Participants presenting respiratory infections during ICU stay
Time frame: Up to Day 90
Participants who present complications related to surgery
Time frame: Up to Day 90
Number of complications related to surgery
Time frame: Up to Day 90
Unexplained haemodynamic worsening
Time frame: Observational Phase: Day 1 and Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 36076483Jativa S, Torrico S, Calle P, Munoz A, Garcia M, Larque AB, Poch E, Hotter G. NGAL release from peripheral blood mononuclear cells protects against acute kidney injury and prevents AKI induced fibrosis. Biomed Pharmacother. 2022 Sep;153:113415. doi: 10.1016/j.biopha.2022.113415. Epub 2022 Jul 18.
- Background: PubMed 17331245Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Esteban Poch López de Briñas principal investigator
Hospital Clinic of Barcelona
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 M2RLAB 001 in people with Acute Kidney Injury, run by M2RLAB SL at 1 site in Spain.
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 10 inclusion and 15 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: paused, as of the sponsor's last update on 21 Sep 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 Spain. 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. Some participants in this study may receive a placebo. 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?
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?
Recovery time of kidney function (time frame: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)). The study lists 6 primary outcomes in all. 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 NCT07052513, which also lists 2 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 21 Sep 2026.