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    Summary
    EudraCT Number:2018-000131-27
    Sponsor's Protocol Code Number:AC17065
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-06-13
    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 number2018-000131-27
    A.3Full title of the trial
    Heme arginate in transplantation - a multi-centre blinded parallel-group randomised trial of heme arginate versus placebo to reduce delayed graft function in kidney transplant recipients. (The HOT 2 Trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised controlled investigation into the efficacy of heme arginate in improving primary graft function in deceased donor kidney transplantation
    A.3.2Name or abbreviated title of the trial where available
    The HOT 2 Trial
    A.4.1Sponsor's protocol code numberAC17065
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Edinburgh
    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 supportKidney Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportOrphan Europe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEdinburgh Clinical Trials Unit, University of Edinburgh
    B.5.2Functional name of contact pointJean Antonelli
    B.5.3 Address:
    B.5.3.1Street AddressUsher Institute, Level 2, Nine Edinburgh Bioquarter, 9 Little France Road
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4UX
    B.5.4Telephone number01316519920
    B.5.6E-mailhot2@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Normosang
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SARL
    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 nameNormosang
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNHuman Hemin
    D.3.9.3Other descriptive nameNormosang
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    End stage renal disease patients undergoing a deceased donor kidney transplant
    E.1.1.1Medical condition in easily understood language
    End stage kidney disease patients undergoing a deceased donor kidney transplant
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does Heme Arginate (HA) result in transplanted kidneys working quicker (reduction in delayed graft function) after transplantation compared with the placebo group.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    •To reduce the requirement for dialysis during the week post transplantation
    •To reduce the number of days to functioning graft
    •To determine if treatment influences renal function and acute rejection rates in the first 3 months
    •To determine whether treatment impacts on early post-transplant quality of life (first 3 months)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients undergoing a kidney only transplant, or a dual kidney transplant, from a deceased donor will be invited to take part.
    • All participants will be at least 18 years old. There is no upper age limit.
    • All patients receiving standard immunosuppression for the individual centre will be included.
    • Meets the co-enrolment criteria outlined in section 4.4 of the protocol
    E.4Principal exclusion criteria
    • Kidney transplant patients as part of a multi-organ transplant e.g. with pancreas or liver
    • Hepatitis C (HCV) +ve donor to HCV –ve recipient
    • Known hypersensitivity to heme arginate
    • Unable to give informed consent
    • Patients with porphyria, irrespective of whether they have ever received heme arginate or not, will be excluded.
    • Previous randomisation into this study (or HOT study)
    • Women who are pregnant or lactating
    • Kidneys that have undergone ex-vivo normothermic perfusion (EVNP)
    • Patients with known liver disease, epilepsy, brain injury or disease.
    E.5 End points
    E.5.1Primary end point(s)
    Delayed Graft Function (DGF) - defined as a failure of a spontaneous fall in creatinine of >10% for each 3 consecutive day period in the first week following transplantation, or equivalent.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily for the first seven days post transplant or until discharge from hospital if before day 7 post-op.
    E.5.2Secondary end point(s)
    i. Requirement for dialysis during the week post transplantation
    ii. Number of days to functioning graft (defined as a spontaneous fall in creatinine of ≥10% over a period of 3 consecutive days in the first 7 days post-transplant, or equivalent).
    iii. Length of stay on index admission for transplant
    iv. Serum creatinine at 1 and 3 months’ post-transplant
    v. Biopsy-proven acute rejection during first 3 months
    vi. SF-36 quality of life questionnaire at days 0 (pre-transplant), 7 and approximately three months post-transplant
    vii. Cost-effectiveness (Cost per QALY gained)
    E.5.2.1Timepoint(s) of evaluation of this end point
    i. Daily for the first seven days post transplant or until discharge from hospital if before day 7 post-op.
    ii. Daily for the first seven days post transplant or until discharge from hospital if before day 7 post-op.
    iii. Confirmed at day 30 post-op if discharge is not within the first 7 days post transplant.
    iv. Assessed/confirmed at follow up appointment on day 90 post-op
    v. Completed at Day 0, 7 and 90 post transplant
    vi. Assessed as part of trial analysis using data collected throughout the course of the patient participation in the trial.
    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) 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 Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA12
    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 Yes
    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
    The end of study is defined as the point at which the trial database is locked following resolution of all data queries by the trial management team and statisticians.

    This definition allows for long term follow up data to be obtained and incorporated into final report within the regulator and sponsor timelines.
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    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 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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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