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    Summary
    EudraCT Number:2014-000308-82
    Sponsor's Protocol Code Number:oxalate01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-000308-82
    A.3Full title of the trial
    Lanthanum Carbonate (Fosrenol®) to reduce oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis: a short-term, prospective, open-label, efficacy and safety clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does Lanthanum Carbonate reduce urinary oxalate output ?
    A.3.2Name or abbreviated title of the trial where available
    The effect of Lanthanum Carbonate on oxaluria.
    A.4.1Sponsor's protocol code numberoxalate01
    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 SponsorUniversitair Ziekenhuis Brussel
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversitair Ziekenhuis Brussel, Department of Nephrology
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel
    B.5.2Functional name of contact pointChristian TIELEMANS
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number3224776055
    B.5.5Fax number3224776230
    B.5.6E-mailctielema@uzbrussel.be
    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 Yes
    D.2.1.1.1Trade name Fosrenol
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    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.3.4Pharmaceutical form Powder for oral suspension
    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 INNLANTHANUM CARBONATE HYDRATE
    D.3.9.1CAS number 54451-24-0
    D.3.9.3Other descriptive nameLANTHANUM CARBONATE HYDRATE
    D.3.9.4EV Substance CodeSUB22941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Fosrenol
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    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.3.4Pharmaceutical form Powder for oral suspension
    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 INNLANTHANUM CARBONATE HYDRATE
    D.3.9.1CAS number 54451-24-0
    D.3.9.3Other descriptive nameLANTHANUM CARBONATE HYDRATE
    D.3.9.4EV Substance CodeSUB22941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Urolithiasis and secondary hyperoxaluria
    E.1.1.1Medical condition in easily understood language
    Kidney stones and increased urinary oxalate output
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    Primary objective: to investigate whether the administration of Lanthanum Carbonate at a dose of 750 mg daily reduces the urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.
    E.2.2Secondary objectives of the trial
    Secondary objectives
    - to investigate whether a dose increase from 750 to 1500 mg Lanthanum Carbonate daily results in a significant decrease in urinary oxalate excretion
    - to investigate the effect of Lanthanum Carbonate on serum phosphorus and urinary phosphorus excretion
    - to evaluate the effect of Lanthanum Carbonate on serum calcium and urinary calcium excretion
    - to assess the evolution of serum Lanthanum levels
    - to assess the safety of Lanthanum Carbonate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18 years or older
    Willing to give Informed Consent
    eGFR > 60 ml/min/1m²73 (CKD-EPI Formula)
    Hyperoxaluaria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
    History of nephrolithiasis
    E.4Principal exclusion criteria
    Allergy to Lanthanum Carbonate
    Hypophosphateamia at baseline (< 0.81 mmol/L)
    Severe known liver insufficiency
    Pregnancy
    Breast feeding
    Female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After first 2-week experimental period (between days 12 and 14)
    E.5.2Secondary end point(s)
    The incremental reduction in urinary oxalate excretion after doubling of the dose of Lanthanum Carbonate from 750 mg to 1500 mg daily, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine
    The proportion of patients developing severe hypophosphatemia after the first and after the second treatment period, defined as serum phosphorus < 0.64 mmol/L
    The evolution of phosphaturia during the study, evaluated by
    - 24-hour urinary phosphorus excretion, expressed in mmol/24 hours
    - urinary phosphorus to creatinine ratio, expressed in mmol phosphorus/g creatinine
    - fractional excretion of phosphorus , expressed in %, defined as (urinary phosphorus (mmol/L) x serum creatinine (mg/dL)) / (serum phosphorus (mmol/L) x urine creatinine (mg/dL))
    The proportion of patients developing hypophosphaturia after the first and after the second treatment period, defined as urinary phosphorus < 12.9 mmol/24 hours
    The evolution of calcemia during the study, expressed in mmol/L (with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L))
    The evolution of calciuria during the study, evaluated by
    - 24-hour urinary calcium excretion, expressed in mmol/24 hours
    - urinary calcium to creatinine ratio, expressed in mmol calcium/g creatinine
    - fractional excretion of calcium, expressed in % defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium(mmol/L) x urine creatinine (mg/dL)), with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L))
    The evolution of mean serum La levels, expressed in mcg/L
    The number and the proportion of patients experiencing adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    After first 2-week treatment period (between days 12 and 14)
    After second 2-week treatment period (between days 26 and 28)
    28 days after last Lanthanum Carbonate administration (between days 54 and 56)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state35
    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
    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 Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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