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    Summary
    EudraCT Number:2025-000122-33
    Sponsor's Protocol Code Number:5354-CL-0301
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-04-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000122-33
    A.3Full title of the trial
    A Phase 3, Multicenter, Prospective, Randomized, Open label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if ASP5354 can clearly help show the ureter during surgery
    A.4.1Sponsor's protocol code number5354-CL-0301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05754333
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/117/2023
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Global Development Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstellas Pharma Global Development Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715455050
    B.5.6E-mailCTU@astellas.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVizify or pudexacianinium chloride
    D.3.2Product code ASP5354
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPudexacianinium chloride
    D.3.9.1CAS number 2243793-22-6
    D.3.9.4EV Substance CodeSUB216538
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    visualisation of ureter
    E.1.1.1Medical condition in easily understood language
    visualisation of ureter
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10068979
    E.1.2Term Imaging procedure
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigator’s blinded conspicuity assessment of the ureter at the first time point for adults with normal renal function or mild renal impairment
    E.2.2Secondary objectives of the trial
    Investigator’s conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure for adults with normal renal function or mild renal impairment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for US study sites) must be obtained from the participant or participant’s parent or legal guardian, and if required, assent from adolescent participant (≥ 12 to < 18 years of age) prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Participant is ≥ 12 years of age at the time of signing an ICF.
    3. Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification.
    4. Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual eGFR using the modification of diet in renal disease (MDRD) formula for adults or the Schwartz formula for adolescents at the screening visit (see [Section 10.7]).
    ● Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min
    ● Adult moderate/severe eGFR cohort: eGFR ≥ 15 to < 60 mL/min
    ● Adolescent cohort: eGFR ≥ 60 mL/min
    5. Female participant is not pregnant (see [Section 10.2]) and at least 1 of the following conditions apply:
    a. Not a woman of childbearing potential (WOCBP; see [Section 10.2])
    b. WOCBP who agrees to follow the contraceptive guidance (see [Section 10.2]) from the time of informed consent through at least 30 days after study intervention administration.
    6. Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration.
    7. Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration.
    8. Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception (see [Section 10.2]) through at least 30 days after ASP5354 administration.
    9. Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration.
    10. Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration.
    11. Participant (and/or participant’s parent or legal guardian) agrees not to participate in another interventional study involving unapproved study medications while participating in the present study.
    E.4Principal exclusion criteria
    1. Participant has any physical or psychiatric condition, which, in the investigator’s opinion, makes the participant unsuitable for study participation.
    2. Participant is anticipated to require ureteral stenting during surgery.
    3. Participant has an active urinary tract infection requiring antibiotic therapy.
    4. Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that the investigator feels would impact safety or study compliance.
    5. Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the investigator.
    6. Participant with body weight < 30 kg.
    7. Participant has a known or suspected hypersensitivity to ASP5354, ICG or any components of the formulation used.
    8. Participant has had previous exposure to ASP5354.
    9. Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery.
    10. Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization.
    11. Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis
    E.5 End points
    E.5.1Primary end point(s)
    Intra-participant difference in ureter conspicuity for WL versus NIR F at 30 (± 15) min after ASP5354 administration. Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 (± 15) min after ASP5354 administration
    E.5.2Secondary end point(s)
    ● Intra-participant comparison of ureter conspicuity scores for the WL 30 (± 15) min time point versus the average of all NIR-F time points
    ● Intra-participant comparison of ureter conspicuity scores for the WL 30 (± 15) min time point versus the end of surgery time point score with NIR F
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 (± 15) min time point versus the average of all NIR-F time points
    30 (± 15) min time point versus the end of surgery time point
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    white light vs NIRF
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 14
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    moderate renally impaired and severe renally impaired patients
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 107
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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