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    Summary
    EudraCT Number:2020-003084-26
    Sponsor's Protocol Code Number:CHK01-01
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-22
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2020-003084-26
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
    Estudo de Fase 3, Aleatorizado, em Dupla Ocultação, Controlado por Placebo de Atrasentan em Doentes com Nefropatia IgA em Risco de Perda Progressiva da Função Renal (O Estudo ALIGN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
    Estudo de Fase 3, Aleatorizado, em Dupla Ocultação, Controlado por Placebo de Atrasentan em Doentes com Nefropatia IgA em Risco de Perda Progressiva da Função Renal (O Estudo ALIGN)
    A.3.2Name or abbreviated title of the trial where available
    the ALIGN Study
    O Estudo ALIGN
    A.4.1Sponsor's protocol code numberCHK01-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04573478
    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 SponsorChinook Therapeutics U.S., 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 supportChinook Therapeutics U.S., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChinook Therapeutics U.S., Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address400 Fairview Ave. North, Suite 900
    B.5.3.2Town/ citySeattle
    B.5.3.3Post codeWA 98109
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12064857051
    B.5.6E-mailclinicaltrials@chinooktx.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.3.4Pharmaceutical 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 codeCHK-01
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Immunoglobulin A Nephropathy (IgAN)
    nefropatia por imunoglobulina A (IgAN)
    E.1.1.1Medical condition in easily understood language
    Immunoglobulin A Nephropathy (IgAN)
    nefropatia por imunoglobulina A (IgAN)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    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 effect of atrasentan versus placebo on proteinuria levels at Week 24
    Avaliar o efeito de atrasentan versus placebo nos níveis de proteinúria na Semana 24
    E.2.2Secondary objectives of the trial
    To evaluate the effect of atrasentan versus placebo on change from baseline to Week 136 (4 weeks post cessation of randomized treatment) in estimated glomerular filtration rate (eGFR)

    To compare 2-year on-treatment rates of change in eGFR between atrasentan and placebo (eGFR slope Week 12 to Week 120 of randomized treatment)

    To compare the total on-study rates of change in eGFR between atrasentan and placebo (eGFR slope from baseline to Week 136)

    Additional efficacy outcomes
    Avaliar o efeito de atrasentan versus placebo na mudança da Baseline à Semana 136 (4 semanas após a interrupção do tratamento aleatorizado) na taxa de filtração glomerular estimada (TFGe)

    Comparar as taxas de mudança de TFGe em tratamento de 2 anos entre atrasentan e placebo (declive de TFGe da Semana 12 à Semana 120 do tratamento aleatorizado)

    Comparar as taxas totais de mudança de TFGe no estudo entre atrasentan e placebo (declive de eTFG da Baselineaté à Semana 136

    Resultados de eficácia adicionais
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional pharmacogenomic sub-study
    Subestudo farmacogenômico opcional
    E.3Principal inclusion criteria
    1. Male and female subjects aged 18 and older at the time of signing the ICF prior to initiation of any study specific activities/procedures.
    2. Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary causes.
    • Biopsy could have occurred at any point in time prior to study.
    • A diagnostic report must be available for review by the Sponsor or designee.
    3. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
    • Investigator discretion should be used in determining maximally tolerated and optimized dose.
    • Subjects who are intolerant to RAS inhibitors are eligible but will not exceed ~5% of total population randomized.
    4. Total urine protein ≥1 g/day as measured via 24-hour urine collection at a central laboratory collected at Screening.
    5. eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
    6. All fertile men and WOCBP must be willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to Baseline.
    7. Willing and able to provide written informed consent and comply with all study visits and study procedures.
    1. Indivíduos do sexo masculino e feminino com 18 anos ou mais no momento da assinatura da CIF antes do início de quaisquer atividades / procedimentos específicos do estudo.
    2. IgAN comprovada por biópsia que, na opinião do Investigador, não seja devida a causas secundárias.
    • A biópsia pode ter ocorrido a qualquer momento antes do estudo.
    • Um relatório de diagnóstico deve estar disponível para revisão pelo Patrocinador ou pessoa designada.
    3. Receber uma dose máxima tolerada e otimizada de um inibidor de RAS que permaneceu estável por pelo menos 12 semanas antes da triagem.
    • O critério do investigador deve ser usado para determinar a dose máxima tolerada e otimizada.
    • Os indivíduos que são intolerantes aos inibidores de RAS são elegíveis, mas não excederão ~ 5% da população total randomizada.
    4. Proteína total na urina ≥1 g / dia medida por meio da coleta de urina de 24 horas em um laboratório central coletada na triagem.
    5. eTFG de pelo menos 30 mL / min / 1,73 m2 na triagem com base na equação CKD-EPI.
    6. Todos os homens férteis e WOCBP devem estar dispostos a aceitar formas altamente eficazes de contracepção, conforme especificado no protocolo, durante todo o estudo e por 1 mês depois. No WOCBP, o uso de anticoncepcionais hormonais deve ter sido iniciado pelo menos 1 mês antes da linha de base.
    7. Disposto e capaz de fornecer consentimento informado por escrito e cumprir todas as visitas e procedimentos do estudo.
    E.4Principal exclusion criteria
    1. Concurrent diagnosis of another cause of chronic kidney disease including diabetic kidney disease or another primary glomerulopathy.
    2. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of Henoch-Schonlein Purpura.
    3. Clinical diagnosis of nephrotic syndrome.
    4. BNP value of > 200 pg/mL at screening.
    5. Platelet count <80,000 per μL at screening
    6. History of organ transplantation (subjects with history of corneal transplant are not excluded).
    7. Use of systemic immunosuppressant medications including systemic corticosteroids (e.g., prednisone, prednisolone, etc.), mycophenolate, azathioprine, cyclosporine, tacrolimus, etc.; use of herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii and Sinomenium acutum; for > 2 weeks in the past 3 months. Use of rituximab within the past 6 months.
    8. Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
    9. Known history of heart failure or prior hospital admissions for conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites.
    10. Known history of clinically significant liver disease or transaminase or bilirubin values more than twice the upper limit of normal. Subjects with treated hepatitis C can be considered for inclusion into the study upon consultation with the Sponsor’s Medical Monitor (or designee).
    11. Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
    12. History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer not requiring ongoing treatment. A subject with curatively treated cervical carcinoma in situ is eligible for this study.
    13. Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females.
    14. Intent to father a child or donate sperm during the study period and at least 1 month afterward for males.
    15. Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2 inhibitors within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.
    16. Concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator or Sponsor’s Medical Monitor (or designee), might confound the results of the study or pose additional risk to the subject by their participation in the study.
    17. History of an alcohol or illicit drug-related disorder within the past 3 years.
    1. Diagnóstico simultâneo de outra causa de doença renal crônica, incluindo doença renal diabética ou outra glomerulopatia primária.
    2. Suspeita clínica de glomerulonefrite rapidamente progressiva (RPGN) com base nas diretrizes KDIGO ou suspeita clínica de púrpura de Henoch-Schonlein.
    3. Diagnóstico clínico de síndrome nefrótica.
    4. Valor de BNP de> 200 pg / mL na triagem.
    5. Contagem de plaquetas <80.000 por μL na triagem
    6. História de transplante de órgãos (indivíduos com história de transplante de córnea não são excluídos).
    7. Uso de medicamentos imunossupressores sistêmicos, incluindo corticosteroides sistêmicos (por exemplo, prednisona, prednisolona, ​​etc.), micofenolato, azatioprina, ciclosporina, tacrolimus, etc .; uso de ervas como Tripterygium Wilfordii Hook F, Caulis sinomenii e Sinomenium acutum; por> 2 semanas nos últimos 3 meses. Uso de rituximabe nos últimos 6 meses.
    8. Pressão arterial confirmada> 150 mmHg sistólica ou> 95 mmHg diastólica com base em uma média de 3 medições obtidas na triagem.
    9. História conhecida de insuficiência cardíaca ou internações hospitalares anteriores por condições relacionadas à sobrecarga de fluidos, como edema pulmonar, edema periférico não controlado, derrame pleural ou ascite.
    10. História conhecida de doença hepática clinicamente significativa ou valores de transaminase ou bilirrubina mais de duas vezes o limite superior do normal. Os indivíduos com hepatite C tratada podem ser considerados para inclusão no estudo após consulta com o Monitor Médico do Patrocinador (ou pessoa designada).
    11. Hemoglobina abaixo de 9 g / dL na triagem ou história prévia de transfusão de sangue para anemia dentro de 3 meses da triagem.
    12. História de malignidade, a menos que esteja livre de câncer por pelo menos 5 anos ou câncer de pele não melanoma que não requeira tratamento contínuo. Um sujeito com carcinoma cervical tratado curativamente in situ é elegível para este estudo.
    13. Gravidez, amamentação ou intenção de engravidar durante o período do estudo e pelo menos 1 mês depois para mulheres.
    14. Intenção de ser pai de um filho ou doar esperma durante o período de estudo e pelo menos 1 mês depois para homens.
    15. Ter recebido qualquer agente experimental ou tratamento aprovado para IgAN (diferente de um inibidor de RAS) incluindo inibidores de SGLT2 dentro de 1 mês (ou 5 meias-vidas do agente, o que for mais longo) antes da triagem. Se o agente em investigação for um agente citotóxico ou imunossupressor, esse período de washout é de 6 meses.
    16. Concorrente clinicamente significativo, instável ou não controlado cardiovascular, pulmonar, hepático, renal, gastrointestinal, geniturinário, hematológico, coagulação, imunológico, endócrino / metabólico ou outro distúrbio médico que, na opinião do investigador ou do monitor médico do patrocinador (ou pessoa designada), pode confundir os resultados do estudo ou representar risco adicional para o sujeito por sua participação no estudo.
    17. História de um transtorno relacionado ao álcool ou drogas ilícitas nos últimos 3 anos.
    E.5 End points
    E.5.1Primary end point(s)
    The change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection) from baseline to Week 24.
    A mudança na proteinúria (proporção de proteína na urina: creatinina [UPCR] com base na coleta de urina de 24 horas) desde o início até a semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    Linha de base para a semana 24
    E.5.2Secondary end point(s)
    Change from baseline to final study visit (Week 136) in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation

    Rate of change in eGFR during 2 years on treatment as measured through a chronic slope calculated from values at Week 12 through to Week 120

    Rate of change in eGFR during the study as measured through a total slope calculated from values at baseline to Week 136
    Mudança da consulta inicial para a visita final do estudo (Semana 136) em eTFG, usando a equação de creatinina da colaboração doença renal crônica-epidemiologia (CKD-EPI)

    Taxa de mudança na eTFG durante 2 anos em tratamento, medida por meio de um declive crônico calculado a partir dos valores da Semana 12 até a Semana 120

    Taxa de mudança na eTFG durante o estudo, medida por meio de uma inclinação total calculada a partir dos valores no início da semana até a semana 136
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to final study visit (Week 136)

    2 years
    Linha de base para a visita de estudo final (Semana 136)

    2 anos
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Colombia
    Hong Kong
    India
    Japan
    Korea, Republic of
    New Zealand
    Taiwan
    United States
    Czechia
    Estonia
    France
    Germany
    Ireland
    Italy
    Poland
    Portugal
    United Kingdom
    Spain
    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 years
    E.8.9.1In the Member State concerned months54
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial months54
    E.8.9.2In all countries concerned by the trial days29
    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: 305
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 320
    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)
    All subjects will be treated per Standard of Care by their physicians.
    Subjects who complete the study may be eligible to enroll in an
    extension study to receive open-label treatment with atrasentan under
    a separate protocol.
    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 Decision2022-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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