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Efficacy and safety of SP16 in preventing Acute Kidney Injury in at-risk subjects with chronic kidney disease undergoing elective cardiac surgery using the heart-lung-machine: A prospective, randomized, double-blind, placebo-controlled clinical trial (EASE-AKI)
EU CTIS ID: 2025-522491-89-00
What this study is testing
To evaluate the safety of SP16 administration and its ability to prevent CSA-AKI as defined by KDIGO criteria, in participants with CKD 2-3b undergoing planned cardiac surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Individual aged ≥18 years.
- Male or female.
- Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic/mitral valve surgery combined with CABG.
- Use of the CPB during surgical intervention expected.
- Written informed consent obtained from the participant.
- Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial.
You likely can't join if
- CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
- Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment.
- Clinical signs of an acute viral infection.
- Serious underlying disease(s) or very poor general medical condition, so that in the investigator’s judgment the person is not expected to survive ICU or hospital stay.
- Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Administration of iodinated contrast agent within 24 hours prior to cardiac surgery.
See the full eligibility criteria
Who can join
- Individual aged ≥18 years.
- Male or female.
- Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic/mitral valve surgery combined with CABG.
- Use of the CPB during surgical intervention expected.
- Written informed consent obtained from the participant.
- Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial.
- CKD Stage 2–3b with eGFR ≤90 and ≥30 ml/min/1.73 m2 (according to 2021 CKD-EPI equation) known for ≥ 3 months prior to enrollment.
- BMI ≥19 kg/m² to ≤40 kg/m².
- Contraceptive measures for female and male participants.
What rules you out
- CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
- Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment.
- Clinical signs of an acute viral infection.
- Serious underlying disease(s) or very poor general medical condition, so that in the investigator’s judgment the person is not expected to survive ICU or hospital stay.
- Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Administration of iodinated contrast agent within 24 hours prior to cardiac surgery.
- Recent (discontinued in the last 14 days before V1a or V1b) or current treatment with immunosuppressive drugs, including, but not limited to, high dose corticosteroids [> 1 mg/kg of prednisone equivalent], tumour necrosis factor alpha blockers, or ciclosporin.
- Current regular use of anti inflammatory drugs such as NSAID, with discontinuation not possible. (however, if these medications are discontinued in the last 10 days before V2, the participant is eligible to participate). ASA up to 100 mg per day is allowed.
- Systemic corticosteroid therapy (any dose).
- Known active chronic inflammatory disease (including, but not limited to, rheumatoid arthritis or systemic lupus erythematosus).
- Known allergy to SP16 or to other ingredients of the IMP.
- Previous cardiac surgery.
- Person who is not willing to use highly effective contraceptive measures (according to CTFG recommendations v1.2).
- Pregnant women.
- Breastfeeding women.
- Current participation in another interventional clinical study (register studies or non-interventional, observational studies excluded).
- Employee or direct relative of an employee of the study site, the CRO, or the Sponsor.
- Person has a kidney transplant or another solid organ transplant.
- Person is scheduled for intermittent or continuous renal replacement therapy (dialysis).
- Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding.
- Known diagnosis of severe COPD (Gold 3) and/or FEV1 < 1 l/s.
- Heart failure with severity of symptoms according to NYHA IV.
- Heart failure with impaired cardiac pump function (LVEF <35%).
- Acute onset or ongoing sepsis - sepsis is defined as the presence of a confirmed or putative infection, along with a dysregulated systemic immune reaction leading to organ dysfunction.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.