Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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 (EASE-AKI)

22 juni 2026 bijgewerkt door: University of Erlangen-Nürnberg Medical School

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)

This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine).

SP16 is an investigational medicinal product that has not yet been approved for clinical use. To date, it has been studied in 28 individuals. The sponsor aims to evaluate whether SP16 can safely reduce or prevent kidney damage associated with the inflammatory and ischemia-reperfusion processes that may occur during cardiac surgery with cardiopulmonary bypass.

Participation in the study extends over a period of slightly more than five months. Screening procedures are performed within approximately seven weeks to two days before the scheduled surgery to determine eligibility for participation. During the hospitalization for cardiac surgery, which is expected to last approximately 10 days, a total of 11 study visits are conducted. Follow-up assessments include a telephone contact approximately one month after hospital discharge and a final on-site study visit approximately three months after discharge.

This is a randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned to receive either SP16 or a placebo, which contains no active ingredient. Neither the participants nor the investigators know which treatment has been assigned during the study period.

Based on previous preclinical and early clinical findings, SP16 may have the potential to reduce or mitigate kidney injury caused by the use of the heart-lung machine during cardiac surgery. However, since the efficacy of SP16 has not yet been proven, no clinical benefit can be guaranteed. Participants receiving placebo are not expected to derive a direct therapeutic benefit from study treatment.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Duitsland
    • Bavaria
      • Erlangen, Bavaria, Duitsland, 91054
        • Universitätsklinikum Erlangen
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Mario Schiffer

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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:

Female participants must fulfil at least one of the following criteria of highly effective contraception (according to CTFG recommendations v1.2) during and up to 3 months after the end of study participation:

  • Menopause (at least 12 months of natural amenorrhoea or 6 months of amenorrhoea with serum FSH >40 mU/ml) OR
  • Condition after bilateral ovariectomy or hysterectomy for at least 6 weeks prior to the screening appointment (Visit 1a, Day 54 to -2) OR

  • Regular, correct and reliable use of a contraceptive method with an error rate ≤1% per year:

    1. Inhibition of ovulation by estrogen and progesterone combination preparations (oral, intravaginal, or transdermal) or
    2. Inhibition of ovulation by progesterone monopreparations (oral, per injectionem [depot injections], or implant) or
    3. Intrauterine device, hormone coil OR
  • Bilateral tubal ligation OR
  • Vasectomy of all partners OR
  • Sexual abstinence.

Male participants must fulfill at least one of the following contraceptive criteria during and up to 3 months after the end of participation in the study:

  • Vasectomy OR
  • Regular, correct, and reliable use of condoms

Exclusion Criteria:

  • CKD stages 4-5 with eGFR <30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
  • Previous cardiac surgery.
  • 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.
  • 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Geneesmiddel: Placebo
In the placebo group, placebo (dextrose 5%) is injected subcutaneously at the same timepoints as the IMP, each time slowly (over about 30 seconds) at a fixed volume of 2 ml each at two different injection sites.
Actieve vergelijker: SP16-3M
Geneesmiddel: SP16-3M

The IMP is injected subcutaneously at two different time points. The first administration will take place pre-surgically, in the area of the operating theatre, when the participant is under anesthesia. The second administration will be performed post-surgically, 9±1 h after the first administration.

At each of the two injection timepoints, a fixed dose of 6 mg SP16-3M is administered by two s.c. injections of 2 ml (concentration 1.5 mg/ml) each at two different injection sites.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frequency of adverse events (AEs) and severe adverse events (SAEs)
Tijdsspanne: Within 72 hours after index surgery
Frequency of adverse events (AEs) and severe adverse events (SAEs) will be assessed within 72 hours after index surgery and SP16 administration.
Within 72 hours after index surgery
Frequency of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)
Tijdsspanne: Within 7 days after index surgery

Number of participants who develop CSA-AKI during hospital stay defined by Kidney Disease: Improving Global Outcomes [organization] (KDIGO) stage 1 or higher. If at least one of the following criteria is observed in the interval since end of index surgery and the 7-day assessment, a participant will be considered to have developed CSA-AKI:

  • Increase in Serum Creatinine (SCr) by ≥0.3 mg/dl (>26.5 μmol/l) within 168±4 hours after index surgery (defined as the period since cardiopulmonary bypass [CPB] was terminated and systemic circulation resumed).
  • Increase in SCr to ≥1.5 times the baseline value, using the highest SCr value within 168±4 hours after index surgery.
  • Decrease in urine output <0.5 ml/kg/h for more than 6 hours within 168±4 h after index surgery
Within 7 days after index surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of post-surgical CSA-AKI
Tijdsspanne: From the timepount of index surgery to the end of surveillance 90±7 days after index surgery
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.
From the timepount of index surgery to the end of surveillance 90±7 days after index surgery
Necessity of renal replacement therapy (RRT)
Tijdsspanne: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
The frequency of RRT post-surgery will be recorded.
From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Duration of renal replacement therapy (RRT)
Tijdsspanne: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Duration of RRT measured by starting date [yyyy-mmm-dd] and end date [yyyy-mmm-dd]
From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Cardiac function on Day 90±7 days after cardiac index surgery
Tijdsspanne: At the end of surveillance 90±7 days after index surgery
Cardiac function on Day 90±7 days after cardiac index surgery compared to pre surgical assessment (Visit 1) assessed by transthoracic echocardiography (TTE).
At the end of surveillance 90±7 days after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery
Tijdsspanne: Within 5 days after index surgery
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).
Within 5 days after index surgery
Concentration of NT-proBNP (serum)
Tijdsspanne: From enrollment to the end of surveillance 90±7 days after index surgery
NT-proBNP serum concentration on Day 1, Day 7, and Day 90±7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).
From enrollment to the end of surveillance 90±7 days after index surgery
Central venous oxygen saturation (ScvO2) (blood gas analysis)
Tijdsspanne: Within 7 days after surgery
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).
Within 7 days after surgery
Frequency of all-cause death
Tijdsspanne: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of all-cause death within 90±7 days (3 months) after cardiac index surgery.
From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function
Tijdsspanne: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function defined as ≥25% increase in Serum Creatinine at Day 90±7 compared to baseline.
From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function requiring at least one dialysis
Tijdsspanne: From enrollment to the end of surveillance 90±7 days after index surgery.
Frequency of sustained impaired renal function requiring at least one dialysis during the post-surgical interval until Day 90±7 (end of observation period).
From enrollment to the end of surveillance 90±7 days after index surgery.
Frequency of AE and SAE within 7 days after cardiac index surgery.
Tijdsspanne: Within 7 days after index surgery
The incidence of adverse events (AEs) and severe adverse events (SAEs) will be assessed in detail in addition to the primary outcome measure within 7 days after cardiac index surgery.
Within 7 days after index surgery
Frequency of AE and SAE during the observation period.
Tijdsspanne: From enrollment to the end of surveillance after 90±7 days after index surgery.
Frequency of AE and SAE during the entire observation period.
From enrollment to the end of surveillance after 90±7 days after index surgery.
Number of participants with at least one SAE
Tijdsspanne: From the first timepoint of SP16 administration to the end of surveillance 90±7 days after index surgery
Number of participants with at least one SAE during the observation period.
From the first timepoint of SP16 administration to the end of surveillance 90±7 days after index surgery
Severity of post-surgical CSA-AKI
Tijdsspanne: Within 7 days after index surgery

Highest CSA-AKI stage value according to the stage classification of the KDIGO-AKI (https://kdigo.org) based on serum creatinine level (mg/dl) and urinary output (ml/kg/hour) in the 7-day period after the index surgery:

Stage 1: serum creatinine level 1.5 to 1.9 times baseline within 7 d OR

≥ 0.3 mg/dl (≥ 26.5 μmol/l) increase within 48 h; urine output < 0.5 ml/kg/h for 6 h Stage 2: serum creatinine level 2.0 - 2.9 times baseline within 7 d; urine output < 0.5 ml/kg/h for ≥ 12 h Stage 3: serum creatinine level 3.0 times baseline OR increase to ≥ 4.0 mg/dl OR Initiation of renal replacement therapy within 7 d; urine output < 0.3 ml/kg/h for ≥ 24 h OR anuria for ≥ 12 h
Within 7 days after index surgery

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time [hours] of the Intensive Care Unit (ICU) stay.
Tijdsspanne: From enrollment to the end of surveillance after 90±7 days after index surgery.
From enrollment to the end of surveillance after 90±7 days after index surgery.
Concentration of Cystatine C (serum)
Tijdsspanne: Before and within 7 days after index surgery
Cystatine C concentration (mg/l) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery
Concentration of NGAL (urine)
Tijdsspanne: Before and within 7 days after index surgery
urine-NGAL concentration (ng/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery
Concentration of IL-6 (serum)
Tijdsspanne: Before and within 7 days after index surgery
IL-6 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery
Concentration of IL-10 (serum)
Tijdsspanne: Before and within 7 days after index surgery
IL-10 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery
Concentration of TIMP2 (urine)
Tijdsspanne: Before and within 7 days after index surgery
TIMP2 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery
Concentration of IGFBP7 (urine)
Tijdsspanne: Before and within 7 days after index surgery
IGFBP7 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Before and within 7 days after index surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Erlangen-Nürnberg Medical School

Medewerkers

Serpin Pharma, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

18 juni 2026

Primaire voltooiing (Geschat)

1 mei 2029

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0740
  • 2025-522491-89-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren