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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 (EASE-AKI)

22. juni 2026 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
120

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Tyskland
    • Bavaria
      • Erlangen, Bavaria, Tyskland, 91054
        • Universitätsklinikum Erlangen
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Mario Schiffer

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Placebo komparator: Placebo
Medicin: 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.
Aktiv komparator: SP16-3M
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of adverse events (AEs) and severe adverse events (SAEs)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of post-surgical CSA-AKI
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time [hours] of the Intensive Care Unit (ICU) stay.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University of Erlangen-Nürnberg Medical School

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Serpin Pharma, LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
18. juni 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. maj 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. maj 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
21. maj 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
16. juni 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. juni 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 0740
  • 2025-522491-89-00 (Ctis)

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