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    Summary
    EudraCT Number:2016-000722-19
    Sponsor's Protocol Code Number:M12-919
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-09
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-000722-19
    A.3Full title of the trial
    A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
    Estudio multicéntrico y de un solo grupo para evaluar los efectos de atrasentán sobre la espermatogénesis y la función testicular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of Atrasentan on sperm production and the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy
    Los efectos de atrasentán sobre la espermatogénesis y la función testicular en sujetos masculinos con diabetes de tipo 1 o 2 y nefropatía
    A.4.1Sponsor's protocol code numberM12-919
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02118714
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901 20 01 03
    B.5.6E-mailabbvie_reec@abbvie.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 nameAtrasentan
    D.3.2Product code ABT-627
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAtrasentan
    D.3.9.1CAS number 195733-43-8
    D.3.9.2Current sponsor codeABT-627
    D.3.9.3Other descriptive nameATRASENTAN
    D.3.9.4EV Substance CodeSUB20598
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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
    Diabetic Nephropathy
    Nefropatía diabética
    E.1.1.1Medical condition in easily understood language
    Type 1 and 2 diabetes and kidney disease
    Diabetes tipo 1 y 2, y enfermedad renal
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    Evaluate the effect of Atrasentan on spermatogenesis and testicular function in men with diabetic nephropathy.
    Evaluar los efectos de Atrasentán sobre la espermatogénesis y la función testicular en hombres con nefropatía diabética
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male subject 30 to 75 years of age, inclusive at the time of Screening.
    • Subject has type 1 or 2 diabetes and is receiving treatment with at least one anti-hyperglycemic medication and ACEi or ARB (RAS inhibitor).
    • Subject has an eGFR ≥ 35 mL/min/1.73 m2 with the CKD-EPI formula and UACR ≥ 30 to < 5,000 mg/g creatinine (≥ 3.4 mg/mmol and < 565 mg/mmol).
    • Subject is able to provide a semen specimen at the required intervals.
    • Subject has a baseline sperm concentration ≥ 30 million per mL at Screening.
    •Varón con una edad comprendida entre los 30 y 75 años, ambos inclusive, en el momento de selección
    •El sujeto tiene diabetes de tipo 1 o 2 y ha recibido tratamiento con al menos un antidiabético y con un IECA o ARA (inhibidor del SRA)
    •El sujeto presenta una FGe ≥ 35 mL/min/1.73 m2 según la fórmula CKD-EPI y un CACO ≥ 30 y < 5000 mg/g de creatinina (≥ 3,4 y < 565 mg/mmol).
    •El sujeto es capaz de proporcionar una muestra de semen en los intervalos establecidos.
    • El sujeto presenta una concentración basal de espermatozoides ≥ 30 millones por ml en la selección.
    E.4Principal exclusion criteria
    • Subject has had treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids, glucocorticoids, ketoconazole, cyclosporine, or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study.
    • Subject is currently receiving or has received hormone replacement therapy within the last 6 months prior to the Screening Period.
    • Subject has a history of severe peripheral edema or facial edema unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial screening visit.
    • Subject has a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring either oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).
    • Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
    •El sujeto ha recibido tratamiento con agentes inhibidores de hormonas, como andrógenos, estrógenos, esteroides anabolizantes, glucocorticoides, ketoconazol, ciclosporina o quimioterapia antineoplásica, en los 6 meses previos a la visita de selección inicial o si está previsto que lo reciba durante el estudio.
    •El sujeto está recibiendo o ha recibido tratamiento de reposición hormonal en los 6 meses previos al período de selección
    •El sujeto tiene antecedentes de edema periférico intenso o edema facial sin relación con traumatismos o antecedentes de mixedema en las 4 semanas previas a la visita de selección inicial.
    •El sujeto tiene antecedentes de hipertensión pulmonar, fibrosis pulmonar o cualquier enfermedad respiratoria que requiera oxigenoterapia (por ejemplo, enfermedad pulmonar obstructiva crónica o enfisema).
    •El sujeto tiene un diagnóstico documentado de insuficiencia cardíaca, ha sido hospitalizado previamente por insuficiencia cardíaca o presenta un conjunto de síntomas (disnea de esfuerzo, edema maleolar, ortopnea, disnea paroxística nocturna) que se consideran compatibles con insuficiencia cardíaca, que no se explican por otras causas y por los cuales se hizo una modificación de la medicación o se administró otro tratamiento dirigido contra la insuficiencia cardíaca.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who have a sperm concentration < 15 million per mL during the 26-week Treatment Period
    Proporción de sujetos que presentan una concentración de espermatozoides < 15 × 106/ml al cabo de 26 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    26-week Treatment Period
    26 semanas de periodo de tratamiento
    E.5.2Secondary end point(s)
    • The proportion of subjects who enter the Observational Period and do not return to within 15% of baseline or above during the 52-week Observational Period.
    • Change from baseline to each visit in sperm concentration.
    • Change from baseline to each visit in each of the components of the semen analysis (sperm motility, sperm morphology, sperm count, semen volume).
    • Change from baseline to each visit in serum testosterone, estradiol, LH, FSH, and inhibin B.
    •Proporción de sujetos que se incorporen al período de observación y cuya concentración de espermatozoides se diferencie en más de un 15 % respecto al valor basal 52 semanas después de la suspensión del tratamiento.
    •Variación entre el momento basal y cada visita de la concentración de espermatozoides.
    •Variación entre el momento basal y cada visita de cada uno de los elementos del seminograma (motilidad de los espermatozoides, morfología de los espermatozoides, concentración de espermatozoides, volumen seminal).
    •Variación entre el momento basal y cada visita de testosterona, estradiol, LH, FSH e inhibina B
    •
    E.5.2.1Timepoint(s) of evaluation of this end point
    First secondary endpoint: 52-week Observational Period
    Last three secondary endpoints: through-out the subject's participation
    Primero y objetivo secundario- 52 semanas de periodo observacional
    Los tres ultimos objetivos secundarios- a través de la participación del sujeto
    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 No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    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.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    Subjects will be treated in accordance with the Investigator's best clinical judgment
    Los sujetos serán tratados de acuerdo al mejor juicio clínico del investigador.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-12
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