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    Summary
    EudraCT Number:2011-005439-20
    Sponsor's Protocol Code Number:1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-005439-20
    A.3Full title of the trial
    A randomised, double-blind study to investigate the effects of intramuscular testosterone undecanoate (Nebido®) on anemia treatment in testosterone deficient men undergoing hemodialysis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of testosterone in male patients on regular hemodialysis
    A.3.2Name or abbreviated title of the trial where available
    DiaTest
    A.4.1Sponsor's protocol code number1
    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 SponsorDept of Renal medicine
    B.1.3.4CountrySweden
    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 supportSwedish Kidney association
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportMartin Rind
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish Medical research Council
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportBayer
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept of Renal medicine
    B.5.2Functional name of contact pointM99, Renal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital at Huddinge
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code141 86
    B.5.3.4CountrySweden
    B.5.4Telephone number046812382532
    B.5.5Fax number04687114742
    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 testosteronundekanoat (Nebido®)
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nametestosteronundekanoat
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 5949-44-0
    D.3.9.3Other descriptive nameTESTOSTERONE UNDECANOATE
    D.3.9.4EV Substance CodeSUB04744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1g/4ml
    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 placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypogonadal males undergoing hemodialysis (HD).
    E.1.1.1Medical condition in easily understood language
    Male dialysis patients with documented low testosterone levels
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 whether Nebido® treatment during 9 months in hypogonadal HD men may translate into lower ESA dose requirements with stable hemoglobin levels within the recommended target interval (100-120 g/l).
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of 9 months of Nebido® treatment to improve muscle mass and nutritional status in testosterone deficient men undergoing stable HD.
    • To assess changes in surrogate markers of inflammation and insulin resistance following 9 months of Nebido® treatment.
    • To assess expected improvements on quality of life and psychological health status following 9 months of Nebido® treatment.
    • To evaluate the health economy of Nebido treatment in ESA-treated HD patients.
    • To assess effect of 9 months of Nebido® treatment on bone health.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ambulant male HD patients (>3 months) at least 18 yrs of age
    • Signed written informed consent obtained
    • Screening non-fasting testosterone <12 nmol/L in two consecutive tests (>2 days apart) on a HD day.
    • Stable ESA dose within the interval equivalent to 25-300 I.U. kg/week during the 6 weeks before inclusion
    • Mean pre-dialysis Hb during screening in the interval 90-120 g/l.
    E.4Principal exclusion criteria
    • Contraindication to treatment with Nebido®, elevation of prostate specific antigen (PSA ≥4.5 ng/ml if <70 yr and ≥6.5 ng/ml if >70 yr) or severe symptomatic benign prostatic hyperplasia
    • Known acute bacterial infection requiring antibiotic treatment
    • Clinically significant overt bleeding
    • Active malignancy
    • Patients taking prednisolone in doses >10 mg
    • Antiandrogens or estrogen medication
    • Uncontrolled epilepsia
    • Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range
    • Planned living donor kidney transplantation
    • Acute coronary syndrome or stroke within the 6 months prior to screening
    • Concomitant, severe psychiatric disorders or other conditions which, in the opinion of the investigator, make participation unacceptable
    • Participation in another interventional clinical trial within previous 30 days
    • Inability to fully comprehend and/or perform study procedures in the investigator’s opinion
    • Patient with very low (<25 U/kg/week) or high (>300 U/kg/week) doses of ESA.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the change in ESA requirements during the study period to maintain stable haemoglobin levels within the target interval of 100-120 g/l.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months treatment period.
    E.5.2Secondary end point(s)
    • Effects on hand grip strength, anthropometric measurements, body composition (by DEXA and bioimpedance) as well as biochemical markers of nutritional status.
    • Effects on inflammatory status
    • Effects on hemoglobin, iron status and other anemia markers
    • Effects on insulin resistance parameters
    • Effects on vascular and cardiovascular health (sphygmocor)
    • Effects on bone health (DEXA and PQcT)
    • Effects on quality of life, psychological health status, hospitalization rates and short-term outcome
    • Effects on DNA methylation
    • Effects on health economy
    • Mortality rate during the study
    • Hospitalization rates during the study period
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months treatment period.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days22
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    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 state40
    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)
    Followed up in clinical routine
    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 Decision2012-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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