Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac SurgeryPhase 1/2MesAKINCT06678399

Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Intravenous Administration of Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery

A Phase 1/2 study testing KELI-101 in people with Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery, run by Kelifarma.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This clinical trial is designed to evaluate KELI-101 versus placebo for the prevention of acute kidney disease leading to chronic kidney disease in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive KELI-101, while the other half will receive a placebo. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
What is being tested?: KELI-101
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: No sites listed yet
Study dates: 1 Apr 2025to 1 Jan 2027
Phase: Phase 1/2
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Pre-operative
Age ≥ 45 years at screening.
Weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below 40; BMI = Body weight (kg) / [Height (m)]2.
Estimated kidney volume within normal ranges (110-190 ml for male and 90-150 ml for female, ultrasound method, ellipsoid formula)
High risk for AKI post CABG development as assessed by investigator e.g., >9 points by Acute Renal Failure after Cardiac Surgery (Thakar Score, Cleveland Clinic Score)
At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position. Sitting vital signs should be within the following ranges:

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oral body temperature between 35.0-37.5 °C
blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg)
pulse rate (50-100/min) stable with or without medication(s) as per Investigator assessment.
Have a pre-operative (baseline) SCr and uNGAL collected within 30 days of surgery (if multiple laboratory results are available within this time window, the most recent SCr and uNGAL values before surgery will be used to establish the baseline)
No known change (increase or decrease) in SCr of ≥25% and uNGAL >200% at screening visit compared to a previous value not older than 6 weeks as documented by a local laboratory using standard assay methodology.
Willing and able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up.
Ability to give informed consent or have a legally acceptable representative do so for them.
Peri-operative
Non-emergent cardiovascular surgery utilizing CPB with >1 hr duration time. Post-operative
≥ 200% rise in uNGAL and uNGAL/Cr from baseline AND above cut-off of 34 ng/mg Cr (in nonCKD patients) within 4 hours of removal from CPB [the timeline and cut-off values TBD after Phase 1 (IA1)]

Who cannot join

Pre-operative
eGFR at screening <30 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation), or on dialysis.
Currently receiving renal replacement therapy.
Patients with bleeding risk at screening. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following:
History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator.
Thrombocytopenia: platelet count< 100x109/L

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Platelet dysfunction: e.g., ADP-induced platelet aggregation lower than 60 %.
Pre-existing coagulation factor deficiency: including, but not limited to, fibrinogen < 2.5-2.8 g/L
Any emergency surgeries performed less than 30 days before screening, including aortic dissection and/or significant congenital heart defects.
Class IV heart failure according to the functional classification of the New York Heart Association (NYHA).
Left ventricular ejection fraction < 30% (based on the last available cardiac ultrasound).
Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest.
Cardiogenic shock or hemodynamic instability within four weeks before surgery, requiring inotropes or vasopressors or mechanical devices such as intra-aortic balloon counter-pulsation (IABP).
Have received cardiopulmonary resuscitation (CPR) within 30 days before cardiac surgery.
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations.
Patients who are post-nephrectomy
Uncontrolled diabetes (glycolyzed HGB <7 or another cut-off as per clinical guidelines for a particular patient)
Have ongoing sepsis, history of sepsis or uncontrolled infection within the past 8 weeks or untreated diagnosed infection before screening visit. Sepsis is defined as the presence of a confirmed pathogen, along with fever or hypothermia and hypoperfusion or hypotension.
Prescribed nephrotoxic medicines (aminoglycosides, glycopeptides, radiocontrast or other agents) within the past week, leading to increased sCr >25%
Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
Pregnant or nursing (lactating) women
Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception while taking study treatment and until the end of the study. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male sterilization (at least 6 months before screening). For female participants in the study, the vasectomized male partner should be the sole partner for that participant.
Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example, hormone vaginal ring or transdermal hormone contraception Peri-, postoperative
Anemia and hemotransfusion.
History of oncological disorders.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Justinas Maciulaitis contact

+37068504325

justinas.maciulaitis@keli.eu

About this study

Official title: Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery

Conditions: Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
Being tested: KELI-101, Vehicle (placebo)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KELI-101Drug
KELI-101 consists of ex vivo expanded placental mesenchymal stromal cells (PMSCs) in a 10% cryopreservation solution.
Vehicle (placebo)Other
Plasmalyte

Study groups in NCT06678399
Study group	Role	What they receive
Low dose	Experimental	Not described Receives: Drug: KELI-101
High dose	Experimental	Not described Receives: Drug: KELI-101
Historical matched-control group	No intervention	Not described
Best dose	Experimental	Not described Receives: Drug: KELI-101
Placebo	Placebo comparator	Not described Receives: Other: Vehicle (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-emergent adverse events (TEAE)
To assess the acute and middle-term toxicity of the intrarenal arterial administration of KELI -101
Measured: From KELI -101 administration up to Day 90
Ratio of the acute kidney disease (AKD) leading to chronic kidney disease (CKD)
To assess the effect of KELI -101 on AKD leading to CKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: From baseline to Day 90

Secondary outcomes (21)

Adverse events (AE) and adverse drug reactions (ADRs)
To assess tolerability and all AE (related or not related to study drug) after IRA administration of KELI -101
Measured: From KELI -101 administration up to Day 90
Serious AE (SAE) and Serious ADRs (SADRs)
To assess all serious AE (related or not related to study drug) after IRA administration of KELI -101
Measured: From KELI -101 administration up to Day 90
Ratio of the highest SCr value within 6 days post-dose versus baseline
To assess the effect of KELI -101 on SCr level, versus mean matched historical control SCr level
Measured: From baseline to Day 7
AKI stages 1, 2 and 3 as defined by modified AKI Network criteria
To assess the effect of KELI -101 on the incidence and severity of AKI in high-risk patients undergoing major cardio-vascular surgery, versus mean matched historical control SCr level
For historical control:
To assess the incidence and severity of AKI in high-risk patients undergoing major cardiovascular surgery in relation to preoperative Scr levels.
Measured: From baseline to Day 7
Ratio of the duration of AKI/AKD at Day 28
To assess the effect of KELI -101 on duration of AKI/AKD
Measured: From baseline to Day 28
Ratio of incidence and duration of renal replacement therapy (RRT) Day 28
To assess the effect of KELI -101 on incidence and duration of RRT
Measured: From baseline to Day 28
Occurrence of major adverse kidney event (MAKE) at Day 7/10/30/90 (MAKE7/10/30/90)
To assess the effect of KELI -101 on Major Adverse Kidney Events composite (MAKE7/10/30/90)
Measured: From Day 7 to Day 90
Occurrence of major adverse reno cardiovascular event at Day 7/10/30/90 (MARCE7/10/30/90)
To assess the effect of KELI -101 on Major Adverse Reno Cardiovascular Events composite (MARCE7/10/30/90)
Measured: From Day 7 to Day 90
Ratio of the AKI leading to CKD
To assess the effect of KELI -101 on incidence of AKI to CKD transition;
Measured: From baseline to Day 90
Ratio of duration of stay in ICU
To assess the effect of KELI -101 on length of ICU-stay
Measured: From baseline to discharge from ICU
Ratio of incidence and completeness of recovery of AKI/AKD at Day 90
To assess the effect of KELI -101 on complete or partial recovery and non-recovery of AKI/AKD
Measured: From baseline to Day 90
Ratio of CKD severity as per eGFR and albuminuria at Day 90
To assess the effect of KELI -101 on sustained decline in renal function
Measured: Day 90
For matched control cohort: Increased uNGAL and uNGAL/Cr in patients that develop AKI
To assess the magnitude of Increased uNGAL and uNGAL/Cr values in urine in patients that develop AKI as compared to those without developed AKI (21 patients for AKI patients and 10 non-AKI patients' cohorts)
Measured: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
For matched control cohort: Prognostic value of increased uNGAL and uNGAL/Cr, duration, and area under curve in patients that develop AKI as compared to patients that do not develop AKI
To assess the magnitude of Increased uNGAL and uNGAL/Cr values, duration, and area under curve in patients that develop AKI as compared to those without developed AKI (21 patients for AKI patients and 10 non-AKI patients' cohorts)
Measured: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
Ratio of the acute kidney disease (AKD) at Day 10 leading to chronic kidney disease (CKD) at Day 90
To assess the effect of KELI -101 on AKD leading to CKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: From baseline to Day 90
Ratio of incidence and duration of RRT Day 28
To assess the effect of KELI -101 on incidence and duration of RRT
Measured: From baseline to Day 28
Occurrence of major adverse kidney event at Day 90 (MAKE90)
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: Day 90
Occurrence of major adverse kidney event at Day 30 (MAKE30)
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: Day 28+2 (Phone call)
Occurrence of individual components of the MAKE criteria at Days 30 or 90
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: Day 28+2 (Phone call)
Occurrence of individual components of the MARCE criteria at Days 7/10/30/90
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Measured: From Day 7 to Day 90
CKD severity as per eGFR and albuminuria at Day 90
To assess the effect of KELI -101 on sustained decline in renal function
Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20251 Jan 2027

First posted7 Nov 2024
Study start1 Apr 2025 (estimated)
Primary completion1 Oct 2026 (estimated)
Study completion1 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac SurgeryStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 91 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06678399
Sponsor's protocol ID: KELI-101
Acronym: MesAKI
Status last verified: Nov 2024
First submitted: 5 Nov 2024
Last updated: 7 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
ClinicalTrials.gov ID: NCT06678399
Acronym / sponsor ID: MesAKI / KELI-101
Conditions: Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 91 participants (estimated)
Lead sponsor: KelifarmaIndustry (pharma, biotech, devices)
Study start: 1 Apr 2025 (estimated)
Primary completion: 1 Oct 2026 (estimated)
Study completion: 1 Jan 2027 (estimated)
First posted: 7 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Low dose	Experimental	Drug: KELI-101
High dose	Experimental	Drug: KELI-101
Historical matched-control group	No intervention	–
Best dose	Experimental	Drug: KELI-101
Placebo	Placebo comparator	Other: Vehicle (placebo)

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Pre-operative
Age ≥ 45 years at screening.
Weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below 40; BMI = Body weight (kg) / [Height (m)]2.
Estimated kidney volume within normal ranges (110-190 ml for male and 90-150 ml for female, ultrasound method, ellipsoid formula)
High risk for AKI post CABG development as assessed by investigator e.g., >9 points by Acute Renal Failure after Cardiac Surgery (Thakar Score, Cleveland Clinic Score)

Key exclusion criteria (28 listed)

Pre-operative
eGFR at screening <30 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation), or on dialysis.
Currently receiving renal replacement therapy.
Patients with bleeding risk at screening. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following:
Any emergency surgeries performed less than 30 days before screening, including aortic dissection and/or significant congenital heart defects.

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
KELI-101KELI-101 consists of ex vivo expanded placental mesenchymal stromal cells (PMSCs) in a 10% cryopreservation solution.	Drug	Best dose, High dose, Low dose
Vehicle (placebo)Plasmalyte	Other	Placebo

Primary outcome

Treatment-emergent adverse events (TEAE)
Time frame: From KELI -101 administration up to Day 90
To assess the acute and middle-term toxicity of the intrarenal arterial administration of KELI -101
Ratio of the acute kidney disease (AKD) leading to chronic kidney disease (CKD)
Time frame: From baseline to Day 90
To assess the effect of KELI -101 on AKD leading to CKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo

21 secondary outcomes

Adverse events (AE) and adverse drug reactions (ADRs)
Time frame: From KELI -101 administration up to Day 90
Serious AE (SAE) and Serious ADRs (SADRs)
Time frame: From KELI -101 administration up to Day 90
Ratio of the highest SCr value within 6 days post-dose versus baseline
Time frame: From baseline to Day 7
AKI stages 1, 2 and 3 as defined by modified AKI Network criteria
Time frame: From baseline to Day 7
Ratio of the duration of AKI/AKD at Day 28
Time frame: From baseline to Day 28
Ratio of incidence and duration of renal replacement therapy (RRT) Day 28
Time frame: From baseline to Day 28
Occurrence of major adverse kidney event (MAKE) at Day 7/10/30/90 (MAKE7/10/30/90)
Time frame: From Day 7 to Day 90
Occurrence of major adverse reno cardiovascular event at Day 7/10/30/90 (MARCE7/10/30/90)
Time frame: From Day 7 to Day 90
Ratio of the AKI leading to CKD
Time frame: From baseline to Day 90
Ratio of duration of stay in ICU
Time frame: From baseline to discharge from ICU
Ratio of incidence and completeness of recovery of AKI/AKD at Day 90
Time frame: From baseline to Day 90
Ratio of CKD severity as per eGFR and albuminuria at Day 90
Time frame: Day 90
For matched control cohort: Increased uNGAL and uNGAL/Cr in patients that develop AKI
Time frame: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
For matched control cohort: Prognostic value of increased uNGAL and uNGAL/Cr, duration, and area under curve in patients that develop AKI as compared to patients that do not develop AKI
Time frame: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
Ratio of the acute kidney disease (AKD) at Day 10 leading to chronic kidney disease (CKD) at Day 90
Time frame: From baseline to Day 90
Ratio of incidence and duration of RRT Day 28
Time frame: From baseline to Day 28
Occurrence of major adverse kidney event at Day 90 (MAKE90)
Time frame: Day 90
Occurrence of major adverse kidney event at Day 30 (MAKE30)
Time frame: Day 28+2 (Phone call)
Occurrence of individual components of the MAKE criteria at Days 30 or 90
Time frame: Day 28+2 (Phone call)
Occurrence of individual components of the MARCE criteria at Days 7/10/30/90
Time frame: From Day 7 to Day 90
CKD severity as per eGFR and albuminuria at Day 90
Time frame: Day 90

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 7 Nov 2024.

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.

Justinas Maciulaitis contact

+37068504325

justinas.maciulaitis@keli.eu

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KELI-101 in people with Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery, run by Kelifarma.

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 16 inclusion and 28 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Justinas Maciulaitis (+37068504325, justinas.maciulaitis@keli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (TEAE) (time frame: From KELI -101 administration up to Day 90). The study lists 2 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 NCT06678399.

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 7 Nov 2024.