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    EudraCT Number:2019-004155-37
    Sponsor's Protocol Code Number:A01-115-02-EU
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2019-004155-37
    A.3Full title of the trial
    A randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects with Type 2 Diabetes and Nephropathy
    Randomizovaná, placebem-kontrolovaná, dvojitě zaslepená, multicentrická studie fáze 2, hodnotící bezpečnost, snášenlivost a účinky látky APX-115 na ledviny u osob s diabetem 2. typu a nefropatií
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-centre Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects with Type 2 Diabetes and Nephropathy
    Multicentrická studie hodnotící bezpečnost, snášenlivost a účinky látky APX-115 na ledviny u osob s diabetem 2. typu a nefropatií.
    A.4.1Sponsor's protocol code numberA01-115-02-EU
    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 SponsorAptabio Therapeutics, Inc
    B.1.3.4CountryKorea, Republic of
    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 supportAptabio Therapeutics, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEUROFINS OPTIMED
    B.5.2Functional name of contact pointPauline Leveille, project manager
    B.5.3 Address:
    B.5.3.1Street Address1 rue des Essarts
    B.5.3.2Town/ cityGières
    B.5.3.3Post code38610
    B.5.4Telephone number+330438372740
    B.5.5Fax number+330438372741
    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.3.2Product code APX-115
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINN Requested
    D.3.9.2Current sponsor codeAPX-115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    diabetic nephropathy
    diabetes 2. typu a nefropatií
    E.1.1.1Medical condition in easily understood language
    diabetic nephropathy
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    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 anti-albuminuric effects of APX-115 in subjects with type 2 diabetes and nephropathy.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of APX-115 in subjects with type 2 diabetes and nephropathy.
    • To evaluate the mean change in eGFR between baseline and Week 12.
    • To assess the pharmacodynamics of APX-115 by measurement of oxidative stress markers

    Exploratory Objective:
    • To evaluate the pharmacokinetics of APX-115 in subjects with type 2 diabetes and nephropathy
    • To evaluate the thyroid function between baseline and week 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Male/female subject, aged 18 to 80 years inclusive at the time of informed consent;
    2- Clinical Diagnosis of type 2 diabetes;
    3- 18.5 kg/m² < BMI < 35 kg/m² ;
    4- First morning void UACR between 200 and 3000 mg/g, inclusive (geometric mean of 2 FMV samples collected on 2 separate days during screening period;
    5- 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening;
    6- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 4 months after the last study drug administration;
    Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
    7- Negative pregnancy test at screening and at randomization;
    8- HbA1c ≤ 10% at screening visit;
    9- Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study. Subject who has not been taking ACE inhibitor or ARB medication may be screened and/or included in the study if he/she has a documented intolerance and/or side effects such as acute kidney injury to ACE inhibitor or ARB medication;
    10- Subject who has been on stable anti-hyperglycemic treatment for at least 3 months prior to screening. For subject whose anti-hyperglycemic treatment includes SGLT2 inhibitor or DPP-4 inhibitor, dose change of these medications is not anticipated to occur during the course of the study;
    11- Willing to be under dietary management for diabetes;
    12- Willing to comply with all study procedures and availability for the duration of the study;
    13- Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form prior to any study procedures.
    E.4Principal exclusion criteria
    1- Female subject who is pregnant or breastfeeding. Female subject should not be enrolled if she plans to become pregnant during the time of study participation;
    2- History of type 1 diabetes mellitus or gestational diabetes;
    3- Subject’s renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease;
    4- History of renal transplant and/or plan to undergo a renal transplant during the course of the study;
    5- History of acute kidney injury (AKI) or renal dialysis within 3 months prior to screening and/or plan to unergo a renal dialysis during the course of the study;
    6- Subject with uncontrolled blood pressure
    o Despite the use of three or more antihypertensive drugs, subject with uncontrolled hypertension with blood pressure greater than SBP 140 mmHg / DBP 90 mmHg
    o Subject with clinically significant hypotension by the discretion of the investigator;
    7- Subject taking two or more RAS blockers (ACE inhibitor, ARB, aldosterone antagonist);
    8- Subject taking immunosuppressant including steroids, cyclosporine, or tacrolimus, or other immunosuppressant drugs;
    9- Clinically significant abnormal laboratory findings at screening including :
    o serum potassium > 5.5 mEq/L;
    o ALT > three times upper limit normal;
    o AST > three times upper limit normal;
    o total bilirubin > three times upper limit normal;
    o serum creatinine > 2 mg/dL;
    10- History of drug or alcohol abuse within 1 year prior to screening;
    11- History of any cardiovascular event (e.g. myocardial infarction, unstable angina within 6 months prior to screening) OR cardiovascular procedure planned during the clinical trial(e.g., revascularization procedure such as stent or bypass graft surgery);
    12- Current or history of NYHA class IV heart failure;
    13- Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization:
    o QTcf ≥ 430 ms for male and ≥ 450 ms for female
    o new clinically important arrhythmia or conduction disturbance;
    14- Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis)
    15- Subject with active urinary tract infection or has not fully recovered before randomization;
    16- History of malignancy within 5 years prior to screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor, is considered cured with minimal risk of recurrence);
    17- Administration of any investigational product within 30 days or within 5 half-lives of the investigational product;
    18- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study;
    19- Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months;
    20- Positive HBs antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests; positive for FANA (at a titre of greater than 1:80), ANCA, RF;
    21- Other medical history which in the opinion of the investigator would make the subject unsuitable for participation in the study;
    22- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental status.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in UACR at Week 12 from baseline in APX-115 treatment group compared to placebo group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12 and baseline
    E.5.2Secondary end point(s)
    • Assessment of safety and tolerability :
    o Adverse Events / Serious Adverse Events;
    o Physical examinations;
    o Vitals signs;
    o Clinical laboratory measurements (chemistry, hematology, coagulation and urinalysis);
    o ECG.
    • Change in eGFR using CKD-EPI formula at Week 12 from baseline in APX-115 treatment group compared to placebo group.
    • Assessment of the pharmacodynamics of APX-115 between baseline and Week 12:
    o Change in plasma biomarkers: MCP-1 and 8-isoprostane
    o Change in urinary biomarkers: 8-isoprostane, kidney injury molecule 1 (KIM-1), Cubilin, and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG)

    Exploratory endpoint
    • Plasma concentrations of APX-115 and other metabolites as appropriate
    • Assessment of the thyroid function: free T4 and TSH
    E.5.2.1Timepoint(s) of evaluation of this end point
    each study visit
    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. 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Czech Republic
    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
    The end of the trial is defined as the last visit of the last subject undergoing the trial
    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 months0
    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 months0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 140
    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)
    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 Decision2020-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
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