Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005825-36
    Sponsor's Protocol Code Number:MAFRI-2
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-06
    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 number2011-005825-36
    A.3Full title of the trial
    Midrodrine, octeotride and albumin for cirrhotic patients with functional renal impairment
    MIDODRINA, OCTEOTRIDA Y ALBÚMINA: EFECTO SOBRE LA FUNCIÓN RENAL DE PACIENTES CON CIRROSIS HEPÁTICA E INSUFICIENCIA RENAL FUNCIONAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Midrodrine, octeotride and albumin for cirrhotic patients with functional renal impairment
    MIDODRINA, OCTEOTRIDA Y ALBÚMINA: EFECTO SOBRE LA FUNCIÓN RENAL DE PACIENTES CON CIRROSIS HEPÁTICA E INSUFICIENCIA RENAL FUNCIONAL
    A.4.1Sponsor's protocol code numberMAFRI-2
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    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 supportN/A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació clinic per a la Recerca Biomèdica
    B.5.2Functional name of contact pointFarmacología Clínica -CTU- Hospital
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754009838
    B.5.5Fax number+34932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 Albúmina Humana Grifols 20% solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    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.3.1Product nameAlbúmina Humana Grifols 20% solución para perfusión
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlbúmina Humana Grifols 20% es una solución que contiene 200 g/l de proteína total, de las cuales al
    D.3.9.1CAS number 46162
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameHUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN
    D.3.9.4EV Substance CodeSUB22285
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 GUTRON 5 mg comprimidos, 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED SPAIN S.L.;
    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.3.1Product nameGUTRON 5 mg comprimidos
    D.3.2Product code 441120
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Buccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDODRINE HYDROCHLORIDE
    D.3.9.1CAS number 3092-17-9
    D.3.9.2Current sponsor codeGutron
    D.3.9.3Other descriptive namemidodrina
    D.3.9.4EV Substance CodeSUB03291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 SANDOSTATIN solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMACÉUTICA, S.A.
    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.3.1Product nameocteotride
    D.3.2Product code 0078-0180
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSANDOSTATIN
    D.3.9.1CAS number 79517-01-4
    D.3.9.2Current sponsor codesandostatin
    D.3.9.3Other descriptive nameOCTREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB03490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    cirrhotic patients
    Cirrosis hepática
    E.1.1.1Medical condition in easily understood language
    cirrhotic patients with functional renal impairment
    cirrosis hepática más insuficiencia renal
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 albumin administration, midodrine and octreotide on renal function in patients with liver cirrhosis with serum creatinine above 1.2 mg / dL.
    Evaluar el efecto de la administración de albúmina, midodrina y octreotido sobre la función renal en pacientes con cirrosis hepática con creatinina sérica superior a 1,2 mg/dL.
    E.2.2Secondary objectives of the trial
    1. To assess the relationship between treatment response and the activity of endogenous vasoactive systems, plasma renin activity, plasma aldosterone, norepinephrine, vasopressin and atrial natriuretic peptide.
    2. To assess the relationship between response to treatment with blood pressure changes measured by Holter tension.
    3. Evaluate the deterioration of renal function in the short term after stopping treatment in responders.
    4. To evaluate the presence of bacterial DNA in blood of patients at different times and its correlation with response to treatment.
    1. Evaluar la relación entre la respuesta al tratamiento y la actividad de los sistemas vasoactivos endógenos: actividad de renina plasmática, concentración plasmática de aldosterona, noradrenalina, vasopresina y el péptido natriurético atrial.
    2. Evaluar la relación entre respuesta al tratamiento con los cambios de tensión arterial medidos por Holter de tensión.
    3. Evaluar el empeoramiento de la función renal a corto plazo tras la suspensión de tratamiento en los pacientes respondedores.
    4. Evaluar la presencia de DNA bacteriano en sangre de pacientes en diferentes momentos y su correlación con respuesta al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 18 and 80 years
    - Liver Cirrhosis
    - Serum Creatinine greater t han 1,2 mg/dL
    - To have given written informed consent
    - Edad entre 18 y 80 años
    - Cirrosis hepática definida por criterios clínicos, analíticos o histológicos (Anexo IX)
    - Insuficiencia renal funcional con una creatinina sérica superior a 1,2 mg/dl.
    - Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta
    E.4Principal exclusion criteria
    - Pregnancy
    - Systolic blood pressure ? 150 mmHg and / or diastolic blood pressure ? 90 mmHg
    - Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
    - Use of antibiotics for seven days prior to inclusion in the study, except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
    - Cardiac or respiratory failure
    - Positive for the human immunodeficiency virus
    - Urinary retention
    - Ischemic heart disease or peripheral vascular disease.
    - Narrow-angle glaucoma
    - Cerebrovascular occlusions
    - Aortic Aneurysm
    - Thyrotoxicosis
    - Pheochromocytoma
    - Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio
    - Tensión arterial sístólica ?150 mmHg y/o tensión arterial diastólica ?90 mmHg
    - Tratamiento previo con derivación transyugular intrahepática portosistémica (TIPS) o shunts quirúrgicos portosistémicos
    - Uso de antibióticos en los siete días anteriores a la inclusión en el estudio, excepto para fines profilácticos (pe. profilaxis de la peritonitis bacteriana espontánea)
    - Insuficiencia cardiaca o respiratoria
    - Positividad para el virus de la imunodeficiencia humana
    - Retención urinaria
    - Enfermedad isquémica cardíaca o vascular periférica.
    - Glaucoma de ángulo estrecho
    - Oclusiones cerebro vasculares
    - Aneurisma aórtico
    - Tirotoxicosis
    - Feocromocitoma
    E.5 End points
    E.5.1Primary end point(s)
    Change in glomerular filtration rate measured by isotopic tests at 12 weeks of starting treatment.
    Cambio en el filtrado glomerular medido mediante pruebas isotópicas a las 12 semanas de iniciar el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in glomerular filtration rate measured by isotopic tests at 12 weeks of starting treatment.
    Cambio en el filtrado glomerular medido mediante pruebas isotópicas a las 12 semanas de iniciar el tratamiento.
    E.5.2Secondary end point(s)
    ? Changes in plasma renin activity, plasma aldosterone and norepinephrine at 4, 12 and 16 weeks.
    ? Changes in blood pressure measured by Holter voltage at 4, 12 and 16 weeks.
    ? Changes in renal function at 4 weeks after cessation of treatment (week 16)
    ? Cambios en la actividad de renina plasmática, concentración plasmática de aldosterona y noradrenalina a las 4, 12 y 16 semanas.
    ? Cambios de tensión arterial medidos por Holter de tensión a las 4, 12 y 16 semanas.
    ? Cambios en la función renal a las 4 semanas tras la suspensión de tratamiento (semana 16)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Changes in plasma renin activity, plasma aldosterone and norepinephrine at 4, 12 and 16 weeks.
    ? Changes in blood pressure measured by Holter voltage at 4, 12 and 16 weeks.
    ? Changes in renal function at 4 weeks after cessation of treatment (week 16)
    ? Cambios en la actividad de renina plasmática, concentración plasmática de aldosterona y noradrenalina a las 4, 12 y 16 semanas.
    ? Cambios de tensión arterial medidos por Holter de tensión a las 4, 12 y 16 semanas.
    ? Cambios en la función renal a las 4 semanas tras la suspensión de tratamiento (semana 16)
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial1
    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 years2
    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 years2
    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: 10
    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 state15
    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)
    N/A
    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 Decision2012-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA