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    Summary
    EudraCT Number:2017-004605-41
    Sponsor's Protocol Code Number:021IGAN17001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004605-41
    A.3Full title of the trial
    A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
    Studio randomizzato, multicentrico, in doppio cieco, a gruppi paralleli, con controllo attivo dell’efficacia e della sicurezza di sparsentan per il trattamento della nefropatia da immunoglobulina A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)
    Efficacia e sicurezza di sparsentan come trattamento della nefropatia da immunoglobulina A
    A.3.2Name or abbreviated title of the trial where available
    Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)
    efficacia e sicurezza di sparsentan per il trattamento della nefropatia da immunoglobulina A
    A.4.1Sponsor's protocol code number021IGAN17001
    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 SponsorRETROPHIN, 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 supportRetrophin, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRetrophin, Inc.
    B.5.2Functional name of contact pointRetrophin Call Center
    B.5.3 Address:
    B.5.3.1Street Address3721 Valley Centre Drive, Suite 200
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number18776595518
    B.5.5Fax number18776595518
    B.5.6E-mailmedinfo@retrophin.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 nameSparsentan compresse
    D.3.2Product code [RE-021]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 254740-64-2
    D.3.9.2Current sponsor codeRE-021
    D.3.9.4EV Substance CodeSUB168607
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Irbesartan tablets
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameover-encapsulated Irbesartan Tablets
    D.3.2Product code C09
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 138402-11-6
    D.3.9.2Current sponsor code43547-0374-03
    D.3.9.4EV Substance CodeSUB08293MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name SMOFKABIVEN - EMULSIONE PER INFUSIONE SENZA ELETTROLITI 1 SACCA BIOFINE MULTICOMPARTIMENTATE DA 493 ML
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameover-encapsulated Irbesartan Tablets
    D.3.2Product code [000000000]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIrbesartan
    D.3.9.1CAS number 138402-11-6
    D.3.9.2Current sponsor codeIRBESARTAN
    D.3.9.3Other descriptive nameIRBESARTAN
    D.3.9.4EV Substance CodeSUB08293MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    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 immunoglobuline A
    E.1.1.1Medical condition in easily understood language
    An autoimmune disease resulting in inflammation of the kidney that can
    lead to kidney failure in approximately one third of patients, over 10-20
    years
    Una patologia autoimmune che risulta in un'infiammazione del rene che può condurre ad insufficienza renale in circa un terzo dei pazienti, in 10-20 anni
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The efficacy objective of the study is to determine the effect of sparsentan on proteinuria and renal function, as compared to an angiotensin receptor blocker, in patients with Immunoglobulin A Nephropathy (IgAN).

    The safety objective of the study is to assess the safety and tolerability of sparsentan by double-blind monitoring of safety endpoints.
    L'obiettivo di efficacia è di determinare l’effetto di sparsentan sulla proteinuria e la funzione renale rispetto a un bloccante del recettore dell’angiotensina, in pazienti con nefropatia da immunoglobuline A (IgAN).
    L'obiettivo di sicurezza è di valutare la sicurezza e la tollerabilità di sparsentan mediante monitoraggio in doppio cieco degli endpoint di sicurezza.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged =18 years.
    2. Biopsy-proven primary IgAN.
    3. Urine total protein value =1.0 g/day at screening.
    4. eGFR =30 mL/min/1.73 m2 at screening.
    5. The patient has been on a stable dose of ACEI and/or ARB therapy for
    at least 12 weeks prior to screening.
    6. At screening, systolic blood pressure =150 mmHg and diastolic blood
    pressure =100 mmHg.
    7. The patient must agree to the use of two forms of contraception.
    1. Maschio o femmina con più di 18 anni.
    2. Glomerulosclerosi focale segmentaria (GSFS) primaria confermata da biopsia o documentazione di una mutazione genetica
    in una proteina dei podociti associata alla GSFS.
    3. Soggetti ambosessi di età compresa tra 18 e 75 anni (Nota:
    pazienti di età inferiore ai 18 anni potrebbero essere arruolati al di fuori del SEE).
    4. Rapporto UP/C =1,5 g/g allo screening.
    5. eGFR =30 ml/min/1,73 m2 allo screening.
    6. Pressione sanguigna media da seduti =100/60 mmHg e =160/100 mmHg.
    7. Il paziente deve acconsentire all’utilizzo di due metodi di
    contraccezione.
    E.4Principal exclusion criteria
    1. IgAN secondary to another condition.
    2. Cellular glomerular crescents present in >25% of glomeruli on renal
    biopsy within 6 months prior to screening.
    3. History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose
    >180 mg/dL at screening.
    4. Any organ transplantation, with the exception of corneal transplants.
    5. Treatment with any of the prohibited concomitant medications.
    6. Treatment with any systemic immunosuppressive medications
    (including corticosteroids) for >2 weeks within 3 months prior to
    screening.
    7. Documented history of heart failure and/or previous hospitalization
    for heart failure or unexplained dyspnea, orthopnea, paroxysmal
    nocturnal dyspnea, ascites, and/or peripheral edema.
    8. Clinically significant cerebrovascular disease and/or coronary artery
    disease.
    9. Jaundice, hepatitis, or known hepatobiliary disease (including
    asymptomatic cholelithiasis), or transaminase levels >2 times the upper
    limit of the normal range at screening.
    10. History of malignancy other than adequately treated basal cell or
    squamous cell skin cancer or cervical carcinoma within the past 2 years.
    11. A screening hematocrit value <27% or hemoglobin value <9 g/dL.
    12. A screening potassium value of >5.5 mEq/L.
    13. Female patient is pregnant, breastfeeding or planning to conceive
    during the study.
    14. Male patient plans to father a child during the course of the study.
    15. Participation in a study of another investigational product within 28
    days prior to screening.
    1. GSFS secondaria a un’altra condizione.
    2.Il paziente presenta aree glomerulari cellulari a mezzaluna presenti in >25% dei glomeruli alla biopsia renale entro 6 mesi prima dello screening.
    3.Anamnesi di diabete mellito di tipo 1, diabete mellito di tipo 2 non controllato (emoglobina A1c [HbA1c] >8%) o glicemia non a digiuno >180 mg/dl allo screening.
    4.Il paziente è stato sottoposto a un qualsiasi trapianto d’organo, esclusi trapianti di cornea.
    5.Il paziente ha bisogno di uno qualsiasi dei farmaci concomitanti proibiti
    6.Il paziente ha assunto eventuali farmaci immunosoppressivi sistemici (inclusi i corticosteroidi) per >2 settimane nei 3 mesi precedenti lo screening.
    7.Il paziente presenta un’anamnesi documentata di insufficienza cardiaca e/o precedente ricovero per insufficienza cardiaca o dispnea inspiegabile, ortopnea, dispnea parossistica notturna, ascite e/o edema periferico.
    8.Il paziente presenta una malattia cerebrovascolare clinicamente significativa e/o arteriopatia coronarica
    9.Il paziente presenta ittero, epatite o malattia epatobiliare nota (compresa la colelitiasi asintomatica), o livelli di alanina aminotransferasi (ALT) e/o aspartato aminotransferasi (AST) >2 volte il limite superiore dell’intervallo di normalità allo screening.
    10.Il paziente presenta un’anamnesi di tumore maligno diverso da carcinoma cutaneo basocellulare o squamocellulare o carcinoma della cervice adeguatamente trattato nei 2 anni precedenti.
    11.Il paziente presenta un valore di ematocrito allo screening <27% o di emoglobina <9 g/dl.
    12.Il paziente presenta un valore di potassio allo screening >5,5 mEq/l.
    13.Il paziente di sesso femminile è in stato di gravidanza o prevede di avviare una gravidanza nel corso dello studio, oppure sta allattando al seno.
    16.Il paziente ha in programma di procreare nel corso dello studio.
    17.Il paziente ha partecipato a uno studio di un altro prodotto sperimentale nei 28 giorni precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:
    The primary efficacy endpoint is the change from baseline in the urine
    protein/creatinine ratio (UP/C) at Week 36.
    Safety Endpoints:
    • Descriptive statistics will be used to summarize the safety data.
    Endpoint di efficacia:
    L’endpoint primario di efficacia è la pendenza dell’eGFR.
    Endpoint di sicurezza:
    • Le statistiche descrittive saranno utilizzate per sintetizzare i dati di sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoints will be evaluated at Week 36. The primary safety endpoint will be evaluated from randomization to Week 114.
    Gli endpoint primari di efficacia saranno valutati alla settimana 36. L'endpoint primario di sicurezza sarà valutato dalla randomizzazione alla settimana 114.
    E.5.2Secondary end point(s)
    Rate of change of eGFR
    Gli endpoint secondari di efficacia comprendono:
    • Percentuale di pazienti che ottengono una riduzione target della proteinuria
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 114
    Dal baseline alla Settimana 114
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Hong Kong
    Korea, Republic of
    New Zealand
    Taiwan
    United States
    Belgium
    Croatia
    Czechia
    Estonia
    France
    Germany
    Italy
    Lithuania
    Poland
    Portugal
    Spain
    United Kingdom
    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 years5
    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 years5
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 280
    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)
    Patients who complete the study will be eligible to enroll in a separate open-label extension study.
    I pazienti che completano lo studio avranno diritto a iscriversi a uno studio di estensione in aperto.
    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 Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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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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