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    Summary
    EudraCT Number:2021-004040-19
    Sponsor's Protocol Code Number:21-ROS-05
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-17
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-004040-19
    A.3Full title of the trial
    A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study to see if RMC-035 is effective and safe in Subjects at High Risk for Acute Kidney Injury following Cardiac Surgery
    A.3.2Name or abbreviated title of the trial where available
    AKITA
    A.4.1Sponsor's protocol code number21-ROS-05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05126303
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGuard Therapeutics International AB
    B.1.3.4CountrySweden
    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 supportGuard Therapeutics International AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuard Therapeutics International AB
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressNybrogatan 34
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code114 39
    B.5.3.4CountrySweden
    B.5.4Telephone number+46733 31 94 38
    B.5.6E-mailtrials@guardtherapeutics.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 nameRMC-035
    D.3.2Product code RMC-035
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRMC-035
    D.3.9.3Other descriptive nameRMC-035
    D.3.9.4EV Substance CodeSUB199763
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number 6.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiac surgery associated acute kidney injury
    E.1.1.1Medical condition in easily understood language
    Condition where the kidneys suddenly stop working properly after heart surgery
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of RMC-035 for prevention of AKI (KDIGO definition) in subjects undergoing CABG and/or valve surgery and/or aorta surgery with additional risk factors for developing cardiac surgery associated AKI
    • To evaluate the safety and tolerability of RMC-035
    E.2.2Secondary objectives of the trial
    •To evaluate RMC-035 for the:
    - prevention of post-operative decline (within 72 hours) in renal function
    - reduction of post-operative AKI duration
    Other Secondary Objectives
    • To evaluate RMC-035 for
    - preserving post-surgery renal function up to Day 90
    - the prevention of post-operative dialysis up to Day 90
    - the prevention of major adverse kidney events (MAKE) at Days 30 and 90, respectively
    •To further evaluate RMC-035 for the:
    - Prevention of AKI within 72 hours (based on cystatin C and/or Urine Output [UO])
    -Persistence and severity of AKI within 72 hours (based on serum creatinine [SCr] and/or UO or cystatin C and/or UO)
    - Prevention, persistence, and severity of AKI within 7 days (based on SCr and/or UO or cystatin C and/or UO)
    - reducing post-operative albuminuria and proteinuria up to Day 90
    • To evaluate the pharmacokinetics of RMC-035
    • Identification and characterization of anti-drug-antibodies (ADA) developed after intravenous administration of RMC-035
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. IRB/IEC approved Informed Consent obtained
    2. Ability to understand and comply with the study requirements and able
    to provide written informed consent
    3. Age ≥18 and <85 years
    4. Estimated glomerular filtration rate (eGFR) is ≥30 mL/min/1.73 m2
    5. Subject is scheduled for non-emergent CABG surgery and/or valve
    surgery and/or ascending aorta aneurysm surgery with use of CPB, and
    AKI risk factors are present at screening
    6. Female subject is not of child-bearing potential, or agreeing not to
    become pregnant
    7. Female subject must not be breastfeeding
    8. Female subject must not donate ova
    9. Male subject and their female spouse/partner(s) who are of childbearing
    potential must be using a highly effective form of birth control
    10. Male subjects must not donate sperm
    11. Subject agrees not to participate in another interventional study
    E.4Principal exclusion criteria
    1. Medical condition that makes the subject unsuitable for study
    participation
    2. Scheduled for emergent surgeries (eg, aortic dissection)
    3. Scheduled for CABG and/or valve surgery and/or ascending aorta
    aneurysm surgery combined with additional non-emergent cardiac
    surgeries (eg, congenital heart defects)
    4. Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
    5. Experiences a cardiogenic shock or hemodynamic instability which
    require inotropes or vasopressors or other mechanical devices within 24 hours prior to surgery
    6. Requirement for defibrillator or permanent pacemaker, mechanical
    ventilation, IABP, LVAD, or other forms of mechanical circulatory support (MCS)
    7. Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery
    8. Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
    9. Ongoing sepsis or an untreated diagnosed clinically significant infection (viral or bacterial)
    10. Total bilirubin or alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN)
    11. History of solid organ transplantation
    12. History of renal replacement therapy (RRT)
    13. Medical condition which requires active immunosuppressive treatment
    14. severe allergic asthma defined as confirmed diagnosis of asthma poorly controlled while receiving high-dose inhaled corticosteroid treatment, or with requirement of a high level of treatment to maintain control
    15. Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
    16. Received an investigational medicinal product within the last 90 days (or within 5 half-lives of the investigational drug, whichever is longer)
    17. Subject has a known allergy to RMC-035 or one of its constituents, or has previously received RMC-035
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • AKI within 72 hours after first dose of IMP based on SCr and/or UO (AKI of any stage/severity according to KDIGO definition, ie, SCr ≥1.5 times baseline, or increase of SCr of ≥0.3 mg/dL [≥26.5 μmol/L], or UO <0.5 mL/kg/h for ≥6 hours)

    Primary Safety Endpoint
    • Nature, frequency and severity of treatment-emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint: 72 hours after first dose of IMP

    Primary Safety Endpoint: As of Signing of Informed Consent until End of Study Visit, number and percentage of subjects with TEAEs and AEs per treatment group
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    • Time-corrected area under the curve (AUC) of SCr for Day 1 to Day 4 (72 hours after first dose of IMP)
    • Duration of AKI defined as the number of days meeting the definition of AKI (KDIGO definition) starting within 72 hours after first dose of IMP until resolution

    Other Secondary Endpoints
    • Post-baseline changes in renal function
    - SCr and cystatin C (and corresponding eGFR values) at 12, 24, 48, and 72 hours, respectively, and at
    Day 7/discharge, Day 30 and Day 90
    - Change from baseline, up to Day 7/discharge, of peak SCr and cystatin C
    • Time-corrected AUC of cystatin C for Day 1 to Day 4 (72 hours after first dose of IMP)
    • Need for renal replacement therapy
    - Dialysis treatment (for any reason) within 72 hours and within 7 days after end of surgery
    - Dialysis free days from end of surgery to Day 30 and Day 90, respectively
    • MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (either SCr, cystatin C, or both) (Levey 2009, Inker 2011, Inker 2012)
    • AKI Characteristics
    - AKI within 72 hours after first dose of IMP based on cystatin C and/or UO (AKI of any stage/severity defined as cystatin C ≥1.5 baseline, OR UO <0.5 mL/kg/h for ≥6 hours)
    - AKI within 7 days after first dose of IMP (based on SCr and/or UO criteria, or cystatin C and/or UO criteria)
    - AKI persistence, defined as an AKI (KDIGO definition) developing within 72 hours after first dose of IMP and with a duration of ≥72 hours. Persistence will also be assessed per AKI severity stage
    - AKI severity stage within 72 hours and within 7 days after first dose of IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until patients' end of study visit 8 according to Schedule of Assessments in the Protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 268
    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)
    Once a subject ended the participation in the trial, the subject should be transferred to local standard of care if needed at the discretion of the investigator or treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-12
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