SP16-3M for Chronic kidney disease | Valvular disease | Cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Individual aged ≥18 years."}
• {"criterion_text":"- Male or female."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Use of the CPB during surgical intervention expected."}
• {"criterion_text":"- Written informed consent obtained from the participant."}
• {"criterion_text":"- Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- BMI ≥19 kg/m² to ≤40 kg/m²."}
• {"criterion_text":"- Contraceptive measures for female and male participants."}

Exclusion criteria

• {"criterion_text":"- CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI."}
• {"criterion_text":"- Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment."}
• {"criterion_text":"- Clinical signs of an acute viral infection."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Administration of iodinated contrast agent within 24 hours prior to cardiac surgery."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Systemic corticosteroid therapy (any dose)."}
• {"criterion_text":"- Known active chronic inflammatory disease (including, but not limited to, rheumatoid arthritis or systemic lupus erythematosus)."}
• {"criterion_text":"- Known allergy to SP16 or to other ingredients of the IMP."}
• {"criterion_text":"- Previous cardiac surgery."}
• {"criterion_text":"- Person who is not willing to use highly effective contraceptive measures (according to CTFG recommendations v1.2)."}
• {"criterion_text":"- Pregnant women."}
• {"criterion_text":"- Breastfeeding women."}
• {"criterion_text":"- Current participation in another interventional clinical study (register studies or non-interventional, observational studies excluded)."}
• {"criterion_text":"- Employee or direct relative of an employee of the study site, the CRO, or the Sponsor."}
• {"criterion_text":"- Person has a kidney transplant or another solid organ transplant."}
• {"criterion_text":"- Person is scheduled for intermittent or continuous renal replacement therapy (dialysis)."}
• {"criterion_text":"- Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding."}
• {"criterion_text":"- Known diagnosis of severe COPD (Gold 3) and/or FEV1 < 1 l/s."}
• {"criterion_text":"- Heart failure with severity of symptoms according to NYHA IV."}
• {"criterion_text":"- Heart failure with impaired cardiac pump function (LVEF <35%)."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Primary safety endpoint: Frequency of AEs and SAEs within 72 h after index surgery.","definition_or_measurement_approach":"Frequency (count) of adverse events (AEs) and serious adverse events (SAEs) occurring within 72 hours after the index surgery; measured by AE/SAE reporting within the 72 h post-surgery window."}
• {"endpoint_text":"- Primary efficacy endpoint: Number of participants who develop CSA-AKI during hospital stay defined by KDIGO stage 1 or higher.","definition_or_measurement_approach":"Count of participants developing cardiac surgery-associated acute kidney injury (CSA-AKI) during hospital stay, defined as KDIGO stage 1 or higher (per KDIGO criteria)."}

Secondary endpoints

• {"endpoint_text":"- Highest CSA-AKI stage value according to the stage classification of the KDIGO-AKI in the 7-day period after the index surgery.","definition_or_measurement_approach":"KDIGO-AKI staging assessed over the 7 days post-surgery; highest stage recorded in that period."}
• {"endpoint_text":"- Number of days after post-surgical onset of CSA-AKI until re-achievement of baseline level of serum creatinine (defined as a return of creatinine to <0.3 mg/dl above baseline value) or discharge from hospital, whichever comes first.","definition_or_measurement_approach":"Time (days) from CSA-AKI onset to either return of serum creatinine to <0.3 mg/dL above baseline or hospital discharge."}
• {"endpoint_text":"- Necessity of RRT (yes/no)","definition_or_measurement_approach":"Binary outcome indicating whether renal replacement therapy (RRT) was required."}
• {"endpoint_text":"- Duration of RRT measured by starting date [yyyy-mmm-dd] and end date [yyyy-mmm-dd]","definition_or_measurement_approach":"Duration calculated from recorded RRT start date to end date."}
• {"endpoint_text":"- Cardiac function on Day 90±7 d after cardiac index surgery compared to pre surgical assessment (Visit 1) assessed by echocardiography (TTE).","definition_or_measurement_approach":"Transthoracic echocardiography (TTE) assessment comparing cardiac function at Day 90±7 to pre-surgical baseline (Visit 1)."}
• {"endpoint_text":"- Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery assessed by point of care echocardiography (TTE) compared to pre-surgical assessment (Visit 1).","definition_or_measurement_approach":"Point-of-care TTE assessments at specified post-operative timepoints compared to pre-surgical baseline."}
• {"endpoint_text":"- NT-proBNP level on Day 1, Day 7, and Day 90±7 d after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).","definition_or_measurement_approach":"Serial NT-proBNP laboratory measurements at the listed timepoints compared to baseline."}
• {"endpoint_text":"- Central venous oxygen saturation (ScvO2) on Day 1, Day 5 and Day 7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).","definition_or_measurement_approach":"ScvO2 measured at specified days and compared to baseline measurements."}
• {"endpoint_text":"- All-cause death within 90±7d (3 months) after cardiac index surgery.","definition_or_measurement_approach":"All-cause mortality recorded within 90±7 days after index surgery."}
• {"endpoint_text":"- Sustained impaired renal function defined as ≥25% increase in SCr at Day 90±7 d compared to baseline.","definition_or_measurement_approach":"Relative increase in serum creatinine ≥25% at Day 90±7 compared with baseline."}
• {"endpoint_text":"- Sustained impaired renal function requiring at least one dialysis during the post-surgical interval until Day 90±7 d (end of observation period).","definition_or_measurement_approach":"Occurrence of at least one dialysis session during follow-up up to Day 90±7."}
• {"endpoint_text":"- Frequency of AE and SAE within 7 days after cardiac index surgery.","definition_or_measurement_approach":"Counts of AEs and SAEs reported within 7 days post-surgery."}
• {"endpoint_text":"- Frequency of AE and SAE during the observation period.","definition_or_measurement_approach":"Counts of AEs and SAEs reported during the full observation period."}
• {"endpoint_text":"- Number of participants with at least one SAE during the observation period.","definition_or_measurement_approach":"Count of participants experiencing one or more SAEs during observation period."}

Germany

Earliest CTIS Part Ii Submission Date

22-01-2026

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

11

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Universitaetsklinikum Erlangen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany