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    Summary
    EudraCT Number:2018-000921-29
    Sponsor's Protocol Code Number:ALLN-177-302
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-000921-29
    A.3Full title of the trial
    Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
    Nachweis der Sicherheit und Wirksamkeit von Reloxaliase (Oxalat-Decarboxylase) bei Patienten mit enteraler Hyperoxalurie: Eine randomisierte, doppelblinde, placebokontrollierte Phase-3-Studie (URIROX-2™)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical research study to evaluate the efficacy and safety of reloxaliase in patients with enteric hyperoxaluria
    A.4.1Sponsor's protocol code numberALLN-177-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03847090
    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 SponsorAllena Pharmaceuticals, 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 supportAllena Pharmaceuticals ,Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Inc
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressTheresienhöhe 28
    B.5.3.2Town/ cityMunchen
    B.5.3.3Post code80339
    B.5.3.4CountryGermany
    B.5.4Telephone number004989895571899
    B.5.5Fax number00498001844276
    B.5.6E-mailregsubmissions@medpace.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 nameReloxaliase (Oxalate decarboxylase)
    D.3.4Pharmaceutical form Capsule
    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 INNRELOXALIASE
    D.3.9.1CAS number 9024-97-9
    D.3.9.2Current sponsor codeReloxaliase (ALLN-177)
    D.3.9.3Other descriptive name oxalate decarboxylase
    D.3.9.4EV Substance CodeSUB192528
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number142
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboCapsule
    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
    Enteric Hyperoxaluria
    E.1.1.1Medical condition in easily understood language
    Excessive urinary oxalate excretion
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020703
    E.1.2Term Hyperoxaluria
    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
    The key objectives of the trial are:
    - determine the efficacy and durability of effect of reloxaliase in reducing UOx excretion in subjects with enteric HOx
    - evaluate the long-term safety of reloxaliase
    - evaluate the long-term effect of treatment with reloxaliase on kidney stone disease progression and kidney function
    - assess impact of treatment with reloxaliase on burden of illness (kidney stone associated healthcare resource utilization)
    E.2.2Secondary objectives of the trial
    Additional objectives are:
    - evaluate long term effect of treatment with reloxaliase on total kidney calcification burden
    - assess impact of treatment with reloxaliase on QoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Has signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC approved informed consent form (ICF) before undergoing any Screening procedure
    2.Is ≥ 18 years of age at Screening
    3.Has an underlying enteric disorder associated with malabsorption (e.g., malabsorptive bariatric surgery a minimum of 12 months prior to screening, inflammatory bowel disease with small bowel involvement, short bowel syndrome, or other malabsorption syndrome) with known or suspected history of HOx (e.g., history of calcium oxalate kidney stones or oxalate nephropathy)
    4.Has UOx excretion ≥ 50 mg/24 hr on an adequate (i.e., appropriate creatinine [mg/kg body weight] for sex) 24-hour urine collection at Screening
    5.Has at least 1 documented kidney stone (spontaneous kidney stone passage or intervention to remove kidney stone, or new or enlarged stone on imaging) within 2 years prior to Screening (See Exclusion Criterion 6)
    6.Has provided 2 adequate 24-hour urine collections at Baseline, with average UOx excretion ≥ 50 mg/24 hr (and neither is < 40 mg/24 hr)
    7.For subjects taking concomitant medication for management of kidney stone risk factors (e.g., thiazides, calcium supplements, alkali therapy, allopurinol): has been on a stable dose regimen for > 8 weeks prior to Screening, and with no changes in dosing (dose level or dosing frequency) anticipated during the first 24 weeks of the study Treatment Period
    8.For female subjects: Is either medically incapable of pregnancy (e.g., has undergone hysterectomy or tubal ligation), is otherwise permanently sterile, or is postmenopausal (defined as minimum 12 consecutive months of amenorrhea not due to an alternative medical cause) or if a woman of childbearing potential, has a negative Screening serum pregnancy test, is not pregnant or nursing at Screening, and agrees to use a highly effective method of birth control for as defined in the protocol for the duration of the study inclusive of the 1 month follow-up period.
    E.4Principal exclusion criteria
    1.Has > 30% variability in the ratio of creatinine (mg)/body weight (kg) among the 3 24-hour urine collections prior to randomization (1 at screening - 2 at baseline)
    2.Has eGFR< 30 mL/minute/1.73 m2 at Screening
    3.Cannot establish Baseline kidney stone burden per study image acquisition requirements
    4.Has a known genetic, congenital, or other cause of kidney stones (e.g., primary hyperoxaluria, cystinuria, primary hyperparathyroidism, medullary sponge kidney), or recent kidney stone (to satisfy Inclusion Criterion 5) was determined to be due to:
    - infection (e.g., struvite stone, recurrent urinary tract infections)
    - medications associated with crystalluria (e.g., carbonic anhydrase inhibitors [acetazolamide, topiramate], triamterene, protease inhibitors, guaifenesin, ephedrine, sulfonamides)
    - medications known to cause fat malabsorption (e.g. orlistat)
    5.Exclusions due to ongoing medication use at screening:
    - Supplemental vitamin C (> 200 mg daily, including multivitamins)
    - Chronic use of long-acting narcotic medication(s), or short-acting/immediate release narcotics at aggregate doses > 50 Morphine Milligram Equivalents (MME)/day
    - Chronic therapy with high doses of systemic steroids use (i.e., > 10 mg/day prednisone or equivalent daily) or intensification of existing immunosuppressant or immunomodulatory therapy for treatment of acute disease flare within 4 weeks prior to Screening or during Screening
    Note: Stable subjects on low chronic dose of steroids or maintenance regimens of other immunosuppressant/immunomodulatory drugs, such as transplant recipients, are not excluded
    6.Any clinically significant finding during Screening (e.g., abnormality on Baseline imaging requiring assessment or intervention, acutely decreased kidney function, or other significant laboratory abnormalities), any ongoing clinically significant illness requiring an intervention or change in management within 4 weeks prior to Screening (e.g., flare of inflammatory bowel disease), or any planned surgical/invasive procedure during the first 24 weeks of the study
    Note: Subjects may be rescreened following resolution of the condition that led them to satisfy this exclusion criterion
    7.Malignancy or treatment for malignancy within 12 months prior to Screening with the exception of localized basal cell or squamous cell skin cancer
    Note: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded
    8.Has received reloxaliase in any other clinical study, or participation in another drug or device clinical trial within 30 days prior to or during Screening
    9.Is not, per Investigator judgment, an ideal clinical trial candidate due to a personal issue or medical condition that is likely to impede successful study completion.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Percent change from Baseline in 24-hour UOx excretion during Weeks 1 to 4

    Primary Long-term Endpoint:
    •Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 1-4
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Percent change from Baseline in 24-hour UOx excretion during Weeks 16 to 24
    • Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour UOx excretion during Weeks 1 to 4 (alternate primary efficacy endpoint for the European Marketing Authorization Application [MAA] submission)
    • Percent change from Baseline in 24-hour UOx excretion during Weeks 1 to 4 and during Weeks 16 to 24 in the bariatric surgery subgroup
    • Change from Baseline in urine supersaturation of calcium oxalate to Weeks 1 to 4 and during Weeks 16 to 24

    Primary Long-term Endpoint:
    • Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
    Secondary Long-term Endpoints:
    • Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones
    • Change in estimated glomerular filtration rate (eGFR) from Baseline

    Exploratory Endpoints:
    • Ordered categorical analysis of the percentage change from Baseline in 24-hour UOx excretion during Weeks 1 to 4 (0 to < 20%, ≥ 20 to < 30%, ≥ 30 to < 40%, ≥ 40 to < 50%, and ≥ 50%).
    • Change in 24-hour UOx excretion in long-term follow-up
    • Proportion of subjects with ≥ 30% reduction in eGFR from Baseline
    • Change in total kidney calcification burden (nephrocalcinosis and kidney stone)
    • Number of events associated with kidney stone disease progression per patient-year at risk
    • Time to kidney stone disease progression
    • Change from Baseline in Wisconsin Stone Quality-of-Life (WisQoL) and Medical Outcomes Study Questionnaire Short-Form 36 Health Survey (SF-36) scores
    • Subgroup analyses of other efficacy parameters by bariatric surgery vs. other enteric condition
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 1-4
    week 16-24

    from baseline to EOS
    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 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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Austria
    Belgium
    Brazil
    Canada
    Croatia
    France
    Germany
    Italy
    Mexico
    Portugal
    Romania
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    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
    LPLV
    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 days0
    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 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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    none patiens will continue on standard of care treatment
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-19
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