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    Summary
    EudraCT Number:2015-000619-42
    Sponsor's Protocol Code Number:PI14/00638
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-000619-42
    A.3Full title of the trial
    An open, Phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome
    Ensayo clínico fase II, abierto, para evaluar la eficacia de la disminución de la absorción intestinal del fósforo en la progresión de la enfermedad renal en pacientes con síndrome metabólico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open, phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome
    Ensayo clínico fase II, abierto, para evaluar la eficacia de la disminución de la absorción intestinal del fósforo en la progresión de la enfermedad renal en pacientes con síndrome metabólico
    A.4.1Sponsor's protocol code numberPI14/00638
    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 SponsorFIBICO
    B.1.3.4CountrySpain
    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 supportFIBICO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBICO
    B.5.2Functional name of contact pointBlanca Quijano Ruíz
    B.5.3 Address:
    B.5.3.1Street AddressMenéndez Pidal, s/n
    B.5.3.2Town/ cityCórdoba
    B.5.3.3Post code14004
    B.5.3.4CountrySpain
    B.5.4Telephone number0034677906567
    B.5.5Fax number0034957010307
    B.5.6E-mailblanca.quijano@imibic.org
    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 AuthorisationSpain
    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 solution in sachet
    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 INNFosrenol 750 mg Powder for oral solution in sachet
    D.3.9.1CAS number 54451-24-0
    D.3.9.2Current sponsor codeV03A E03
    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 typeup to
    D.3.10.3Concentration number750
    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
    Chronic kidney disease and metabolic syndrome
    Enfermedad renal cronica y sindrome metabolico
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease and metabolic syndrome
    Enfermedad renal cronica y sindrome metabolico
    E.1.1.2Therapeutic area Not possible to specify
    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
    Demonstrate that decreased urinary excretion of phosphorus, by administration of a phosphate binder (lanthanum carbonate) reduces the progression of chronic kidney disease CKD patients diagnosed with stage 2-3 and metabolic syndrome.
    Demostrar que la disminución de la excreción urinaria de fósforo, mediante la administración de un quelante de fósforo (Carbonato de Lantano), reduce la progresión de la enfermedad renal crónica en pacientes CKD estadio 2-3 y diagnosticados de síndrome metabólico.
    E.2.2Secondary objectives of the trial
    Evaluate the effectiveness of decreased phosphorus excretion of:
    - Parameters of cardiovascular function: Endothelial function, pulse wave velocity.
    - Parameters related to the metabolic syndrome and inflammation.
    - Detection of predictive biomarkers of kidney damage.
    -parameters of mineral metabolism: PTH, FGF23, Klotho, Vit D (1,25 (OH) D, 25 (OH) D) serum calcium and phosphorus, urinary calcium excretion, urinary excretion of phosphorus.
    ? To assess the safety of medication research
    Evaluar la eficacia de la disminución de la excreción urinaria de fósforo sobre:
    - parámetros de función cardiovascular: Función endotelial, velocidad de onda pulso.
    - parámetros relacionados con el síndrome metabólico e inflamación.
    - detección de biomarcadores predictores de daño renal.
    -parámetros de metabolismo mineral: PTH, FGF23, Klotho, Vit D (1,25(OH) D, 25 (OH)D) Calcio y fósforo en suero, Excreción urinaria de calcio , excreción urinaria de fosforo.
    ?Evaluar la seguridad de la medicación en investigación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have previously participated in the study entitled "Influence of phosphorus excretion on the progression of renal damage: Mechanisms and clinical studies" and belonging to the group formed by tertile 2 + 3, according to the ratio between urinary excretion of phosphorus and creatinine (P / Cr).
    2. Subjects of both sexes with age range between 18 and 85 years.
    3. Patients with metabolic syndrome, defined by the presence of three or more of the diagnostic criteria established in the Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity (Alberti et al Circulation 2009; 120:.. 1640-1645):
    (1) high waist circumference (women ?88 cm, man ?102 cm)
    (2) elevated triglycerides (?150 mg / dL) or use of specific medication
    (3) reduced HDL (men <40 mg / dL, women <50 mg / dL) or use of specific medication
    (4) impaired fasting glucose (?100 mg / dL) or use of antidiabetic medication
    (5) hypertension (systolic blood pressure ?130 or diastolic ?85 mm Hg or respectively) or use of antihypertensive medication.
    4. Glomerular filtration rate estimated by the formula CKD-EPI, between 30 and 90 ml / min / 1.73m2. (stages 2 and 3 of the classification of chronic kidney disease)
    5. Patient able to understand the study procedures and granted their informed consent trial participation.
    1. Pacientes que han participado previamente en el estudio titulado: ?Influencia de la excreción de fósforo sobre la progresión del daño renal: Mecanismos y estudios clínicos?, y que pertenecen al grupo formado por el tercil 2+3, de acuerdo al ratio entre excreción urinaria de fósforo y creatinina (P/Cr).
    2. Sujetos de ambos sexos con rango de edad de entre 18 y 85 años.
    3. Pacientes con síndrome metabólico, definido por la presencia de tres o más de los criterios diagnósticos establecidos en el Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity (Alberti et al. Circulation. 2009;120:1640-1645):
    (1) perímetro abdominal elevado (mujeres ?88 cm, hombre ?102 cm)
    (2) triglicéridos elevados (?150 mg/dL) o uso de medicación específica
    (3) HDL reducido (hombres<40 mg/ dL, mujeres<50 mg/dL) o uso de medicación específica
    (4) glucosa en ayunas alterada (?100 mg/dL) o uso de medicación antidiabética
    (5) hipertensión arterial (presión arterial sistólica ó diastólica ?130 o ?85 mm Hg respectivamente) o uso de medicación antihipertensiva.
    4. Filtrado glomerular, estimado por la fórmula CKD-EPI, entre 30 y 90 ml/min/1.73m2. (estadios 2 y 3 de la clasificación de enfermedad renal crónica)
    5. Paciente capaz de comprender los procedimientos del estudio y que otorga su consentimiento informado para participación en el ensayo.
    E.4Principal exclusion criteria
    1. hyperphosphataemic defined as phosphorus concentration greater than 5 mg / dl.
    2. Patients with clinical signs of congestive heart failure.
    3. Active infections within 30 days prior to baseline.
    4. Patients with systemic inflammatory disease.
    5. HIV infection, Hepatitis C and Hepatitis B.
    6. History of cancer within the previous five years.
    7. Chronic liver disease.
    8. immunosuppressive therapy.
    9. Pregnant women, breastfeeding, or planning to become pregnant.
    10. Addiction to drugs or alcohol in the investigator's opinion, may interfere with the fulfillment of study requirements.
    11. Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.
    12. Changes 5% higher glomerular filtration regarding renal function available prior to inclusion in the study
    1. Pacientes con hiperfosfatemia, definida como concentración de fósforo superior a 5 mg/dl.
    2. Pacientes con manifestación clínica de insuficiencia cardiaca congestiva.
    3. Infecciones activas dentro de los 30 días anteriores al inicio del estudio.
    4. Pacientes con enfermedad inflamatoria sistémica.
    5. Infección por VIH, virus de la Hepatitis C o Hepatitis B.
    6. Historia de cáncer dentro de los 5 años anteriores.
    7. Hepatopatía crónica.
    8. Terapia inmunosupresora.
    9. Mujeres embarazadas, en lactancia, o con planes de quedar embarazadas.
    10. Adicción a drogas o alcohol que, en opinión del investigador, podría interferir con el cumplimiento de los requisitos de estudio.
    11. Incapacidad o falta de voluntad del individuo o tutor legal o representante para dar consentimiento informado por escrito.
    12. Cambios superiores al 5% en el filtrado glomerular respecto a la función renal disponible previa a la inclusión en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    GFR measured by creatinine clearance (formula MDR / CKD-EPI ml / min / 1.73m2)
    filtrado glomerular medido por aclaramiento de creatinina (fórmula MDR/CKD-EPI ml/min/1.73m2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every three months for 12 months and every 6 months for 24 months
    Cada tres meses durante 12 meses y cada 6 meses durante 24 meses
    E.5.2Secondary end point(s)
    cardiovascular function parameters: Endothelial function, pulse wave velocity.
    - Parameters related to the metabolic syndrome and inflammation.
    - Detection of predictive biomarkers of kidney damage.
    -parameters of mineral metabolism: PTH, FGF23, Klotho, Vit D (1,25 (OH) D, 25 (OH) D) serum calcium and phosphorus, urinary calcium excretion, urinary excretion of phosphorus.
    parámetros de función cardiovascular: Función endotelial, velocidad de onda pulso.
    - parámetros relacionados con el síndrome metabólico e inflamación.
    - detección de biomarcadores predictores de daño renal.
    -parámetros de metabolismo mineral: PTH, FGF23, Klotho, Vit D (1,25(OH) D, 25 (OH)D) Calcio y fósforo en suero, Excreción urinaria de calcio , excreción urinaria de fosforo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    GFR measured by creatinine clearance (formula MDR / CKD-EPI ml / min / 1.73m2)
    Cada tres meses durante 12 meses y cada 6 meses durante 24 meses
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no tratamiento
    no treatment
    E.8.2.4Number of treatment arms in the trial3
    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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state99
    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
    Ninguno
    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 Decision2015-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-31
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