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    Summary
    EudraCT Number:2020-003084-26
    Sponsor's Protocol Code Number:CHK01-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    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)
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo su Atrasentan in pazienti con nefropatia IgA a rischio di perdita progressiva della funzione renale (Studio 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)
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo su Atrasentan in pazienti con nefropatia IgA a rischio di perdita progressiva della funzione renale (Studio ALIGN)
    A.3.2Name or abbreviated title of the trial where available
    ALIGN
    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 Address100-1600 Fairview Avenue East
    B.5.3.2Town/ citySeattle
    B.5.3.3Post codeWA 98102
    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.3.2Product code [Atrasentan]
    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.3.9.4EV Substance CodeSUB20598
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 da immunoglobulina A (IgAN)
    E.1.1.1Medical condition in easily understood language
    Immunoglobulin A Nephropathy (IgAN)
    Nefropatia da immunoglobulina 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
    Valutare l'effetto di atrasentan rispetto al placebo sui livelli di proteinuria alla settimana 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)
    Valutare l'effetto di atrasentan rispetto al placebo sulla variazione dal basale alla settimana 136 (4 settimane dopo la cessazione del trattamento randomizzato) della velocità di filtrazione glomerulare stimata (eGFR)

    Confrontare i tassi di variazione dell'eGFR a 2 anni durante il trattamento tra atrasentan e placebo (pendenza eGFR dalla settimana 12 alla settimana 120 del trattamento randomizzato)

    Confrontare i tassi totali di variazione dell'eGFR durante lo studio tra atrasentan e placebo (pendenza dell'eGFR dal basale alla settimana 136)
    E.2.3Trial contains a sub-study No
    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. UPCR =1 g/g (=1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
    5. eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
    6. 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. Soggetti maschi e femmine di età pari o superiore a 18 anni al momento della firma dell'ICF prima dell'inizio di qualsiasi attività / procedura specifica dello studio.
    2. IgAN comprovata da biopsia che, a parere dello sperimentatore, non è dovuta a cause secondarie.
    • La biopsia potrebbe essersi verificata in qualsiasi momento prima dello studio.
    • Un rapporto diagnostico deve essere disponibile per la revisione da parte dello sponsor o del designato.
    3. Ricezione di una dose massimamente tollerata e ottimizzata di un inibitore della RAS che è rimasta stabile per almeno 12 settimane prima dello screening.
    • La discrezione dello sperimentatore deve essere utilizzata per determinare la dose massima tollerata e ottimizzata.
    • I soggetti che sono intolleranti agli inibitori RAS sono eleggibili ma non supereranno il 5% circa della popolazione totale randomizzata.
    4. UPCR =1 g / g (=1000 mg / g) sulla base di una valutazione del laboratorio centrale dell'urina della prima minzione mattutina raccolta allo screening.
    5. eGFR di almeno 30 mL / min / 1,73 m2 allo screening basato sull'equazione CKD-EPI.
    6. Disponibilità a rispettare forme di contraccezione altamente efficaci, come specificato nel protocollo, durante lo studio e per 1 mese dopo. Nella WOCBP, l'uso di contraccettivi ormonali deve essere iniziato almeno 1 mese prima del basale.
    7. Disponibilità e capacità di fornire il consenso informato scritto e rispettare tutte le visite e le procedure di studio.
    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. Diagnosis of nephrotic syndrome with serum albumin < 3 g/dL at screening.
    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 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 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. Diagnosi concomitante di un'altra causa di malattia renale cronica inclusa la malattia renale diabetica o un'altra glomerulopatia primaria.
    2. Sospetto clinico di glomerulonefrite rapidamente progressiva (RPGN) sulla base delle linee guida KDIGO o sospetto clinico di porpora di Henoch-Schonlein.
    3. Diagnosi di sindrome nefrosica con albumina sierica <3 g / dL allo screening.
    4. Valore BNP> 200 pg / mL allo screening.
    5. Conta piastrinica <80.000 per µL allo screening
    6. Storia di trapianto d'organo (non sono esclusi soggetti con storia di trapianto di cornea).
    7. Uso di farmaci immunosoppressori sistemici inclusi micofenolato, azatioprina, ciclosporina, tacrolimus, ecc .; uso di erbe come Tripterygium Wilfordii Hook F, Caulis sinomenii e Sinomenium acutum; per> 2 settimane negli ultimi 3 mesi. Uso di rituximab negli ultimi 6 mesi.
    8. Pressione sanguigna confermata> 150 mmHg sistolica o> 95 mmHg diastolica sulla base di una media di 3 misurazioni ottenute allo screening.
    9. Anamnesi nota di insufficienza cardiaca o precedenti ricoveri ospedalieri per condizioni relative a sovraccarico di liquidi come edema polmonare, edema periferico non controllato, versamento pleurico o ascite.
    10. Anamnesi nota di malattia epatica clinicamente significativa o valori di transaminasi o bilirubina più del doppio del limite superiore della norma. I soggetti con epatite C trattata possono essere considerati per l'inclusione nello studio previa consultazione con il Medical Monitor dello Sponsor (o designato).
    11. Emoglobina inferiore a 9 g / dL allo screening o precedente anamnesi di trasfusione di sangue per anemia entro 3 mesi dallo screening.
    12. Anamnesi di tumore maligno a meno che non sia esente da cancro da almeno 5 anni o cancro della pelle non melanoma che non richieda un trattamento continuo. Un soggetto con carcinoma cervicale in situ trattato curativamente è idoneo per questo studio.
    13. Gravidanza, allattamento o intenzione di rimanere incinta durante il periodo di studio e almeno 1 mese dopo per le femmine.
    14. Intenzione di generare un figlio o donare sperma durante il periodo di studio e almeno 1 mese dopo per i maschi.
    15. Aver ricevuto un agente sperimentale entro 1 mese (o 5 emivite dell'agente, a seconda di quale sia più lunga) prima dello screening. Se il file sperimentale
    l'agente è un agente citotossico o immunosoppressore, quindi questo periodo di washout è di 6 mesi.
    16. Disturbi concomitanti clinicamente significativi, instabili o non controllati cardiovascolari, polmonari, epatici, renali, gastrointestinali, genito-urinari, ematologici, della coagulazione, immunologici, endocrini / metabolici o di altro tipo che, secondo l'opinione dello Sperimentatore o del Monitor medico dello sponsor (o designato), potrebbero confondere i risultati dello studio o rappresentare un rischio aggiuntivo per il soggetto con la sua partecipazione allo studio.
    17. Storia di un disturbo correlato all'alcol o alle droghe illecite negli ultimi 3 anni.
    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.
    La variazione della proteinuria (rapporto proteine urinarie: creatinina [UPCR] basato sulla raccolta delle urine nelle 24 ore) dal basale alla settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    Dal basale alla settimana 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
    Modifica dal basale alla visita finale dello studio (settimana 136) in eGFR, utilizzando l'equazione della creatinina della collaborazione tra malattia renale cronica ed epidemiologia (CKD-EPI)

    Tasso di variazione dell'eGFR durante 2 anni di trattamento misurato attraverso una pendenza cronica calcolata dai valori alla settimana 12 fino alla settimana 120

    Tasso di variazione dell'eGFR durante lo studio misurato attraverso una pendenza totale calcolata dai valori al basale alla settimana 136
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to final study visit (Week 136)

    2 years
    Dal basale alla visita finale dello studio (settimana 136)

    2 anni
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Hong Kong
    India
    Japan
    Korea, Republic of
    New Zealand
    Taiwan
    United States
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    Argentina
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    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.
    Tutti i soggetti saranno trattati secondo lo Standard of Care dai loro medici.
    I soggetti che completano lo studio possono essere idonei a iscriversi a un
    studio di estensione per ricevere un trattamento in aperto con atrasentan sotto un protocollo separato.
    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 Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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