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    Summary
    EudraCT Number:2011-006168-30
    Sponsor's Protocol Code Number:RLH_Pentoxifylline_Dec2011
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-006168-30
    A.3Full title of the trial
    PEntoxifylline in Anaemia Resistant to erythropoietin (PEAR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pentoxifylline in EPOr
    A.3.2Name or abbreviated title of the trial where available
    Pentoxifylline in EPOr
    A.4.1Sponsor's protocol code numberRLH_Pentoxifylline_Dec2011
    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 SponsorR&D, Barts and The London NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportBiomedical Research Unit
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarts and The London NHS Trust
    B.5.2Functional name of contact pointDr Stanley FAN
    B.5.3 Address:
    B.5.3.1Street AddressRoyal London Hospital
    B.5.3.2Town/ cityWhitechapel
    B.5.3.3Post codeE1 1BB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442073777480
    B.5.5Fax number442073777003
    B.5.6E-mails.fan@qmul.ac.uk
    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 TRENTAL 400
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis
    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 nameTrental400 (Pentoxyphylline)
    D.3.2Product code PL 04425/0213
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    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
    We shall study patients with renal failure on dialysis. We shall particularly focus on patients with evidence of erythopoeitin stimulating agent (ESA) resistance.
    E.1.1.1Medical condition in easily understood language
    Patients with renal failure on dialysis who are not responding well to a treatment for anaemia (EPO)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10014647
    E.1.2Term End stage renal failure
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effects Pentoxifylline in ESA resistant ESRD patients on haemodialysis.

    The primary study endpoints is the ESA requirement relative to the Hb level (is there a difference in a randomised placebo controlled cross-over study)?
    E.2.2Secondary objectives of the trial
    Secondary endpoints include:
    • Safety analysis
    • Hb values and ESA doses after 6 months of treatment.
    • Blood sampling will be performed at the start of each hemodialysis session every month. These samples may be subjected to additional analyses to further characterize the pro- and anti-inflammatory effects of pentoxifylline including CRP.
    • DNA telomere length shortening
    • Radiological imaging will be performed at Baseline and at 6 months. The effect IMP has on the following radiological parameters will be examined:
    _
    _
    _
    _
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
    • Willing to comply with study restrictions;
    • Between 18 and 65 years of age (inclusive).
    • Diagnosis of clinically stable ESRD, as determined by the investigator;
    • Requiring regular dialysis therapy for at least 12 weeks prior to first administration of study agent;
    • Receiving treatment with IV or SC erythropoietin receptor agonist at least weekly (ie exclude Micera or other ESAs given fortnightly or monthly) for a minimum of 8 weeks prior to administration of study agent, requiring doses to remedy EPO-resistance (requiring >12,000iu equivalent of EPO per week), with evidence of stable hemoglobin levels;
    • Baseline hemoglobin values between 9.0 and 12.0 g/dL before entering the study;
    • CRP levels of ≥5 mg/L
    E.4Principal exclusion criteria
    • Clinically relevant abnormal history of physical and mental health other than conditions related to chronic kidney disease of patient, as determined by medical history taking (as judged by the investigator);
    • Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to chronic kidney disease of patient (as judged by the investigator);
    • Subject has uncontrolled hypertension;
    • Subject is unable to refrain from the use of disallowed concomitant medication from one week prior to the first study drug administration until follow-up assessments (see section 3.3);
    • Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug that might interfere with the primary or secondary endpoints;
    • Subject has undergone major surgery within six months prior to screening;
    • Any other condition that in the opinion of the investigator would complicate or compromise the study (e.g. known haemoglobinopathy), or the well being of the subject.
    • Females of child-bearing potential who are not willing to use contraception for the duration of the study.
    • Subject is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients.
    • Subjects with recent cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias

    E.5 End points
    E.5.1Primary end point(s)
    Endpoints: The primary study endpoints is the ESA requirement relative to the Hb level.
    E.5.2Secondary end point(s)
    Secondary endpoints include:
    • Safety analysis
    • Hb values and ESA doses after 6 months of treatment.
    • Blood sampling will be performed at the start of each hemodialysis session every month. These samples may be subjected to additional analyses to further characterize the pro- and anti-inflammatory effects of pentoxifylline including CRP.
    • DNA telomere length shortening
    • Radiological imaging will be performed at Baseline and at 6 months. The effect IMP has on the following radiological parameters will be examined:
    _
    _
    _
    _
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study (cross-over design)
    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 No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 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
    After the last visit of the last subject in the study
    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 months6
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-10-15. Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    We shall inform potential subjects of child bearing capacity that they should use contraception during the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 will return to the standard care (as receiving prior to enrollment assuming their clinical condition has not changed).
    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 Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-06-10
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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