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    Summary
    EudraCT Number:2012-004178-24
    Sponsor's Protocol Code Number:RP-OSV-02-D
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004178-24
    A.3Full title of the trial
    Study to investigate the therapeutic equivalence of OsvaRen® tablets and OsvaRen® granules
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing whether the new drug formulation of OsvaRen granules is as efficacious and as safe as Osvaren tablets.
    A.3.2Name or abbreviated title of the trial where available
    OsvaRen NEW
    A.4.1Sponsor's protocol code numberRP-OSV-02-D
    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 SponsorFresenius Medical Care Deutschland GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFresenius Medical Care Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFresenius Medical Care Deutschland GmbH
    B.5.2Functional name of contact pointR&D, Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressDaimlerstrasse 15
    B.5.3.2Town/ cityBad Homburg
    B.5.3.3Post code61352
    B.5.3.4CountryGermany
    B.5.4Telephone number4961726094172
    B.5.5Fax number496172269835
    B.5.6E-mailfrank.laukhuf@fmc-ag.com
    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 No
    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 nameOsvaRen Granules
    D.3.4Pharmaceutical form Granules
    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 INNCalcium acetate
    D.3.9.1CAS number 62-54-4
    D.3.9.3Other descriptive nameCALCIUM ACETATE
    D.3.9.4EV Substance CodeSUB13160MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number435
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium carbonate, heavy
    D.3.9.1CAS number 546-93-0
    D.3.9.3Other descriptive nameMAGNESIUM CARBONATE HEAVY
    D.3.9.4EV Substance CodeSUB12126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number235
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 OsvaRen film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Nephrologica Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Tablet
    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 INNCalcium acetate
    D.3.9.1CAS number 62-54-4
    D.3.9.3Other descriptive nameCALCIUM ACETATE
    D.3.9.4EV Substance CodeSUB13160MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number435
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium carbonate, heavy
    D.3.9.1CAS number 546-93-0
    D.3.9.3Other descriptive nameMAGNESIUM CARBONATE HEAVY
    D.3.9.4EV Substance CodeSUB12126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number235
    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
    Hyperphosphataemia in end stage renal failure patients on extracorporeal renal replacement therapy
    E.1.1.1Medical condition in easily understood language
    Dialysis dependant patients with increased levels of serum phosphate
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    Demonstrating the therapeutic equivalence of OsvaRen granules versus tablets.
    E.2.2Secondary objectives of the trial
    Comparing OsvaRen® granules and OsvaRen® tablets with regard to the number of patients reaching serum phosphate levels < 1.76 mmol/l and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and parathyroid hormone (PTH) are of interest.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consent form is obtained prior to starting the screening visit
    • Male and female patients 18–75 years of age with dialysis dependent renal failure (CKD 5D)
    • Patients have been on 3x/week in-centre renal replacement therapy for at least 6 months on either high-flux HD or OL-/HDF
    • Prescribed haemodialysis session duration is ≥ 4 hours
    • spKt/V ≥ 1.20 according to last in-centre measurement prior the study enrolment
    • Patients have been on OsvaRen® tablets for at least 12 weeks as sole phosphate binder as sole phosphate binder and the titration phase has been completed according to physician´s discretion
    • Patients are able to take the study medication as prescribed particularly OsvaRen® granules (packed in stickpacks)
    • Patients are willing to stop any calcium, magnesium or vitamin D containing supplements
    • Patients are willing to maintain their typical diet with regards to phosphate uptake for the time of the study
    • Patients are willing to comply with the study protocol
    E.4Principal exclusion criteria
    • Pregnant women (by blood ß-hCG pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or
    • Patients with a life expectancy shorter than the planned duration of the study or
    • Patients with any acute or chronic severe disease potentially interfering with study outcomes or
    • Patients with PTH levels > 800 ng/l or
    • Patients who participated in an interventional clinical study during the preceding 30 days or
    • Patients suffering from any other, not mentioned condition which could interfere with the patient’s ability to comply with the study or
    • Patients who previously participated in the same study
    E.5 End points
    E.5.1Primary end point(s)
    Serum phosphate levels
    E.5.1.1Timepoint(s) of evaluation of this end point
    Comparing serum phosphate levels after 4 weeks of treatment with
    a) test drug (OsvaRen granules)
    and
    b) comparator drug (OsvaRen tablets)
    E.5.2Secondary end point(s)
    - Number of patients with serum phosphate levels <1.76 mmol/l
    - Difference in serum phosphate levels between the first and last visit for each treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparing quoted end points after 4 weeks of treatment with
    a) test drug (OsvaRen granules)
    and
    b) comparator drug (OsvaRen tablets)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Therapeutic equivalence of OsvaRen granules with OsvaRen tablets.
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    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 years0
    E.8.9.1In the Member State concerned months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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
    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 Decision2013-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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