CClinicalTrials.gg
Sign In
Not yet recruitingNCT06678399MesAKIUpdated Nov 7, 2024

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 interventional study of KELI-101 and Vehicle (placebo) in Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery, sponsored by Kelifarma. Not yet recruiting. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Kelifarma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 91 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

This is the only study on the registry with Kelifarma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Pre-operative

  1. Age ≥ 45 years at screening.
  2. 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.
  3. Estimated kidney volume within normal ranges (110-190 ml for male and 90-150 ml for female, ultrasound method, ellipsoid formula)
  4. 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)

  5. 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:

    1. oral body temperature between 35.0-37.5 °C
    2. blood pressure (systolic 100-160 mmHg, diastolic \< 100 mmHg)
    3. pulse rate (50-100/min) stable with or without medication(s) as per Investigator assessment.
  6. 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)
  7. 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.
  8. Willing and able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up.

  9. Ability to give informed consent or have a legally acceptable representative do so for them.

    Peri-operative

  10. Non-emergent cardiovascular surgery utilizing CPB with >1 hr duration time. Post-operative
  11. ≥ 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)]

Exclusion criteria

Exclusion Criteria:

Pre-operative

  1. eGFR at screening \<30 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation), or on dialysis.
  2. Currently receiving renal replacement therapy.

  3. 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:

    1. History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator.
    2. Thrombocytopenia: platelet count\< 100x109/L
    3. Platelet dysfunction: e.g., ADP-induced platelet aggregation lower than 60 %.
    4. Pre-existing coagulation factor deficiency: including, but not limited to, fibrinogen \< 2.5-2.8 g/L
  4. Any emergency surgeries performed less than 30 days before screening, including aortic dissection and/or significant congenital heart defects.
  5. Class IV heart failure according to the functional classification of the New York Heart Association (NYHA).
  6. Left ventricular ejection fraction \< 30% (based on the last available cardiac ultrasound).
  7. Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest.
  8. 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).
  9. Have received cardiopulmonary resuscitation (CPR) within 30 days before cardiac surgery.
  10. 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.
  11. Patients who are post-nephrectomy
  12. Uncontrolled diabetes (glycolyzed HGB \<7 or another cut-off as per clinical guidelines for a particular patient)
  13. 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.
  14. Prescribed nephrotoxic medicines (aminoglycosides, glycopeptides, radiocontrast or other agents) within the past week, leading to increased sCr >25%
  15. Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
  16. Pregnant or nursing (lactating) women

  17. 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:

    1. 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.
    2. 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.
    3. 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.
    4. 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
  18. Anemia and hemotransfusion.
  19. History of oncological disorders.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
91 participants (estimated)

Study arms

  • Experimental
    Low dose

    Drug: KELI-101

  • Experimental
    High dose

    Drug: KELI-101

  • No intervention
    Historical matched-control group
  • Experimental
    Best dose

    Drug: KELI-101

  • Placebo comparator
    Placebo

    Other: Vehicle (placebo)

Interventions

  • DrugKELI-101

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

  • OtherVehicle (placebo)

    Plasmalyte

06

What researchers measure

Primary outcomes

  1. Treatment-emergent adverse events (TEAE)

    To assess the acute and middle-term toxicity of the intrarenal arterial administration of KELI -101

    Time frame: From KELI -101 administration up to Day 90

  2. 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

    Time frame: From baseline to Day 90

Secondary outcomes

  1. 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

    Time frame: From KELI -101 administration up to Day 90

  2. 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

    Time frame: From KELI -101 administration up to Day 90

  3. 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

    Time frame: From baseline to Day 7

  4. 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.

    Time frame: From baseline to Day 7

  5. Ratio of the duration of AKI/AKD at Day 28

    To assess the effect of KELI -101 on duration of AKI/AKD

    Time frame: From baseline to Day 28

  6. 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

    Time frame: From baseline to Day 28

  7. 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)

    Time frame: From Day 7 to Day 90

  8. 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)

    Time frame: From Day 7 to Day 90

  9. Ratio of the AKI leading to CKD

    To assess the effect of KELI -101 on incidence of AKI to CKD transition;

    Time frame: From baseline to Day 90

  10. Ratio of duration of stay in ICU

    To assess the effect of KELI -101 on length of ICU-stay

    Time frame: From baseline to discharge from ICU

  11. 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

    Time frame: From baseline to Day 90

  12. 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

    Time frame: Day 90

  13. 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)

    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

  14. 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)

    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

  15. 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

    Time frame: From baseline to Day 90

  16. Ratio of incidence and duration of RRT Day 28

    To assess the effect of KELI -101 on incidence and duration of RRT

    Time frame: From baseline to Day 28

  17. 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

    Time frame: Day 90

  18. 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

    Time frame: Day 28+2 (Phone call)

  19. 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

    Time frame: Day 28+2 (Phone call)

  20. 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

    Time frame: From Day 7 to Day 90

  21. CKD severity as per eGFR and albuminuria at Day 90

    To assess the effect of KELI -101 on sustained decline in renal function

    Time frame: Day 90

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06678399
Lead sponsor
Kelifarma
Responsible party
Sponsor
First posted
Nov 7, 2024
Start date
Apr 1, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 7, 2024

Study contacts

Justinas Maciulaitis
Contact
justinas.maciulaitis@keli.eu
+37068504325

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acute Kidney Injury→

Start the discussion