Modified autologous leukocyte cells for the treatment of acute kidney injury after cardiac surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

M2rlab S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

29 Apr 2026 → ongoing

Decision date (initial)

2024-08-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

M2rlab S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

1. Assessment of the efficacy of cell therapy versus placebo by measuring the time to recovery of renal function in patients who develop AKI within 48 h after cardiac surgery.
2. To assess the safety and tolerability of cell therapy versus placebo in patients who develop AKI within 48 h after cardiac surgery.

Secondary objectives 10

1. Assessment of MAKE occurrence in patients who have received cell therapy vs placebo
2. Assessment of the efficacy of cell therapy vs placebo in patients who develop AKI within 48 h after cardiac surgery by assessing the need for and duration of renal replacement therapy
3. Assessment of the efficacy of cell therapy vs placebo in patients who develop AKI within 48 h after cardiac surgery by assessing the need for and length of ICU stay and hospital stay
4. Assessment of the efficacy of cell therapy vs placebo in patients who develop AKI within 48 h after cardiac surgery by assessing survival at 30 and 90 days
5. Assessment of the efficacy of cell therapy vs placebo in patients who develop AKI within 48 h after cardiac surgery by assessing survival and need for dialysis at 30 and 90 days.
6. Assessment of the efficacy of cell therapy vs. placebo in patients who develop AKI within 48 h after cardiac surgery by assessing creatinine levels during admission
7. Assessment of the efficacy of cell therapy vs placebo in patients developing AKI within 48 h after cardiac surgery by assessing the progression of renal injury
8. Assessment of the safety and tolerability of cell therapy vs placebo in patients who develop AKI within 48 h after cardiac surgery by assessing the incidence of infectious complications
9. Assessment of the safety and tolerability of cell therapy vs placebo in patients developing AKI within 48 h after cardiac surgery by assessing the occurrence of surgery-related complications
10. Assessment of the safety and tolerability of cell therapy vs placebo in patients developing AKI within 48 h after cardiac surgery by assessing the evolution of ventricular function

Conditions and MedDRA coding

Acute kidney injury after cardiac surgery

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients of both sexes over 18 years of age being able to understand and sign the informed consent.
2. Patients undergoing elective or emergent valvular and/or coronary heart surgery performed with extracorporeal circulation.
3. Meet one of the following two criteria: a) Present a preoperative AKI risk ≥ 30% according to the Leicester Cardiosurgery score, if the informed consent form (ICF) is signed before cardiac surgery. b) Have signed the ICF within the first 12 hours after the diagnosis of AKI
4. Present AKI in the first 48 hours after cardiac surgery, according to one of the classifications defined by the AKIN (Acute Kidney Injury Network) scale.
5. In the case of women or men of childbearing age, for safety, those who agree to follow the required contraceptive measures from hospital discharge until the end of their participation in the clinical trial.

Exclusion criteria 15

1. Stage IV or V CKD (glomerular filtration rate [GFR] < 30 ml/min)
2. AKI in the month prior to cardiac surgery.
3. Patients who have previously undergone renal replacement therapy.
4. Patients who, due to their clinical condition (hemodynamic instability, oliguria, present or foreseeable volume overload), are expected to start renal replacement therapy within 48 hours after diagnosis of AKI.
5. Interstitial glomerulonephritis or vasculitis.
6. Pregnancy.
7. Breastfeeding women.
8. History of renal transplant.
9. Endocarditis.
10. Patients with mechanical assist devices: extracorporeal membrane oxygenator (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
11. Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] <30%)
12. Post-surgical septic infection.
13. Clinically significant anemia with hemoglobin values below 100 g/L.
14. Positive serologies 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 evaluated once it has been confirmed that the patient has developed AKI.
15. Participation in another clinical intervention test

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Renal function recovery time
2. Proportion of patients with no persistently altered creatinine values (>31% of baseline values) 7 days after AKI episode
3. Occurrence of adverse events (AEs), serious AEs (SAEs), AEs resulting in discontinuation of study treatment, AEs of special interest

Secondary endpoints 10

1. Reducing the incidence of MAKE ** **MAKE (major adverse kidney events): death, dialysis, or permanent reduction in estimated glomerular filtration rate (CKD-EPI) of >30% of baseline value.
2. Number of patients on renal replacement therapy and duration of therapy
3. Duration of ICU admission (days). Duration (days) of hospital stay of the patients
4. Global survival at 30 days. Global survival at 90 days.
5. Global survival at 30 days. Number of patients on dialysis at 30 days. Global survival at 90 days. Number of patients on dialysis at 90 days
6. Maximum creatinine values (peak creatinine) recorded during the patients' hospitalisation and time (days) when the maximum peak occurs
7. Improved levels of injury biomarkers in urine
8. Patients presenting: Surgical wound infections; Respiratory infections during ICU stay
9. Complications related to surgery: Sternotomy; Re-intervention; Circulatory support
10. Unexplained hemodynamic impairment: - Drop in cardiac index to <2.5 L/min/m2 (if previously higher) and/or - Drop in systemic systolic blood pressure >30% or <90 mmHg and/or Increased dose of vasoactive drugs > 30%

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

M2rlab S.L.

Sponsor organisation

M2rlab S.L.

Address

Calle De Juan Bravo 10

City

Madrid

Postcode

28006

Country

Spain

Scientific contact point

Organisation

M2rlab S.L.

Contact name

Xavier Ginesta Buch

Public contact point

Organisation

M2rlab S.L.

Contact name

Pablo García de la Riva Mestre

Third parties 2

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications