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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-003084-26
    Sponsor's Protocol Code Number:CHK01-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedPoland - Office for Medicinal Products
    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)
    Randomizowane, prowadzone metodą podwójnie ślepej próby z grupą kontrolną otrzymującą placebo badanie fazy III dotyczące stosowania atrasentanu u pacjentów z nefropatią IgA zagrożonych postępującym upośledzeniem czynności nerek (badanie 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)
    Randomizowane, prowadzone metodą podwójnie ślepej próby z grupą kontrolną otrzymującą placebo badanie fazy III dotyczące stosowania atrasentanu u pacjentów z nefropatią IgA zagrożonych postępującym upośledzeniem czynności nerek (badanie ALIGN)
    A.3.2Name or abbreviated title of the trial where available
    the ALIGN Study
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/21/2542
    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)
    E.1.1.1Medical condition in easily understood language
    Immunoglobulin A Nephropathy (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
    Open Label Extension: to further characterize the safety of atrasentan
    E.2.2Secondary objectives of the trial
    To evaluate the effect of atrasentan versus placebo in estimated glomerular filtration rate (eGFR)
    Additional efficacy outcomes
    Open Label Extension: to evaluate the effect of atrasentan on proteinuria
    (endpoint of change in UPCR based on 24-hour urine collection from OL
    baseline to OLE Week 36)
    Open Label Extension: to evaluate the effect of atrasentan on eGFR
    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 pharmacogenetic sub-study
    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 (applicable only to non-SGLT2i stratum)
    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 who engage in heterosexual intercourse 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.

    SGLT2i Stable Stratum Only
    8. Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that have been stable for at least 12 weeks prior to Screening.

    Open Label Extension
    9.Subjects who provided written informed consent for OL extension prior to initiation of any OL-specific activities/procedures and are willing to
    comply with all study visits and study procedures.
    10.Subjects from the double-blind portion of study who have completed treatment throguh Week 132 and completed the Week 136 visit.
    Note: Subjects who were randomized to the non-SGLT2i stratum in the double-blind portion of the study may start SGLT2i during the OL
    extension
    11.Subjects entering the OL extension must enroll and have their OLBaseline visit within 14 days of Week 136 (OL Screening visit).
    Note: If enrollment in the OL extension was not possible due to administrative delays, patients who have completed the EOS visit in the
    double-blind portion of the study may be able to enroll in the open-label extension if less than 90 days have passed since their EOS visit after
    approval by Sponsor's Medical Monitor. If enrollment in the OL extension is > 30 days after Week 136, the patient must repeat the Week 136
    laboratory assessments to confirm eligibility.
    12. All fertile men and WOCBP who engage in heterosexual intercourse 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 contraceptive agents must have been continued after completing the double-blind portion of the study.
    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 (IgA vasculitis).
    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, nefecon, 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 RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stratum) 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.

    Refer to Sections 6.10.1 and 6.10.2 for details regarding prohibited and restricted medications, respectively.

    Open Label Extension:
    18.Plan to receive any investigational agent (other than atrasentan) or approved treatment for IgAN (other than a RAS inhibitor or SGLT2i).
    Other ETA receptor antagonists will not be allowed during OL extension. Additional exclusion criteria included in the study protocol under Appendix 6, Section 3.2 (not included here due to character limit)
    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 36 (non-SGLT2i stratum).

    Open Label Extension:
    •Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)
    •Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI) including events of fluid overload
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 36
    Open Label Extension: OL baseline to OL week 52
    E.5.2Secondary end point(s)
    Change from baseline to final study visit (Week 136, 4 weeks post end of treatment) in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum).

    • Percent of subjects meeting the composite endpoint of experiencing at least one of the following during the study
    (non-SGLT2i stratum):
    o At least a 30% reduction in eGFR sustained for at least 30 days
    o eGFR <15 mL/min/1.73m2, sustained for at least 30 days
    o Chronic dialysis, ≥30 days
    o Kidney transplantation
    o All-cause mortality
    • Percent of subjects meeting the composite endpoint of experiencing at least one of the following during the study
    (non-SGLT2i stratum):
    o At least a 40% reduction in eGFR sustained for at least 30 days
    o eGFR <15 mL/min/1.73m2, sustained for at least 30 days
    o Chronic dialysis, ≥30 days
    o Kidney transplantation
    o All-cause mortality
    • Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36 and a 25% decrease in total urine
    protein from Baseline (non-SGLT2i stratum).
    Open Label Extension:
    •Change from OL Baseline to OL Week 36 in UPCR based on 24-hour urine collection
    •Change from OL Baseline to OL Week 52 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine
    equation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to final study visit (Week 136, 4 weeks post end of treatment)
    Open Label Extension:
    •OL Baseline to OL Week 36 (UPCR)
    •OL Baseline to OL Week 52 (eGFR)
    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 Yes
    E.8.1.7.1Other trial design description
    Open Label Extension
    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 trial3
    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 EEA55
    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
    Colombia
    New Zealand
    Hong Kong
    Taiwan
    Australia
    Brazil
    Canada
    China
    India
    Japan
    Korea, Republic of
    United Kingdom
    United States
    France
    Germany
    Italy
    Poland
    Portugal
    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 years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 369
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 384
    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 Decision2021-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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