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    Summary
    EudraCT Number:2008-004748-36
    Sponsor's Protocol Code Number:PA-CL-03A
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-29
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-004748-36
    A.3Full title of the trial
    An open-label, randomized, active controlled multi center phase II dose finding study to evaluate the ability of PA21 to lower serum phosphate levels and the tolerability in patients with chronic kidney disease on maintenance hemodialysis
    A.4.1Sponsor's protocol code numberPA-CL-03A
    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 SponsorVifor (International) Inc.
    B.1.3.4CountrySwitzerland
    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 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 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 namePA21
    D.3.2Product code YT325
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeXR500
    D.3.9.3Other descriptive namePA21
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Renagel 800 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSevelamer 800 mg film-coated tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSevelamer
    D.3.9.1CAS number 52757956
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Hyperphosphatemia in patients with chronic kidney disease on maintenance hemodialysis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020712
    E.1.2Term Hyperphosphatemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the ability of different doses of PA21 to lower serum phosphate levels in patients with chronic kidney disease on maintenance hemodialysis
    E.2.2Secondary objectives of the trial
    To assess the efficacy/safety profiles of the different doses of PA21
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent.
    2. Men and women ≥ 18 years of age,
    3. Receiving stable maintenance hemodialysis 3 times a week for ≥ 3 months before screening,
    4. Being on restricted phosphate diet at screening and throughout study, and being compliant with prescribed phosphate binders, as per Investigator judgment,
    5. Receiving stable doses of phosphate binder for at least 1 month before screening,
    6. Patients receiving therapy with vitamin D, vitamin D metabolites or calcimimetics must be on a constant dose for a least 1 month prior to screening and must remain on the same dose throughout the study,
    7. Having stable calcium content in dialysate for at least 1 month prior to screening,
    8. Able to read and write with sufficient competence to understand the study procedures and capable of giving legal consent,
    9. Patients who receive therapy with erythropoietin must be on a constant dose for at least 1 month before screening and must remain on the same dose throughout the study,
    To be eligible for randomization and to enter into the treatment period, the patients must have:
    10. Serum phosphate levels >1.78 mmol/L (5.5 mg/dL) (Value at Week -1, D2 or D3). If the serum phosphate level is > 1.78 mmol/L (>5.5 mg/dL) already at Week 1, D2, then the patient can be randomized (in Week 1, D1) without waiting for the results of the serum phosphate level at Week 1, D3.
    E.4Principal exclusion criteria
    Patients cannot be enrolled in this study if they meet one or more of the following exclusion criteria:
    1. Uncontrolled hyperphosphatemia (>2.5 mmol/L [7.75 mg/dL]) while on conventional phosphate binders (value at screening),
    2. Hypercalcemia (serum calcium >2.5 mmol/L [>10.0 mg/dL]) at screening or during washout,
    3. Serum calcium < 1.9 mmol/L (<7.6 mg/dL) at screening or during washout,
    4. Severe hyperparathyroidism (iPTH levels >600 ng/L),
    5. Intention to initiate therapy with vitamin D, vitamin D metabolites or calcimimetics during the study or / and non-stable therapy with vitamin D, vitamin D metabolites or calcimimetics (if applicable),
    6. Known history of non-response to phosphate binders,
    7. Known hypersensitivity to PA21, sevelamer (as Renagel® or Renvela®), or to any of their excipients, or iron allergy,
    8. Pregnancy or lactation (patients with a positive pregnancy test will leave the study and may be rescreened once about 2 weeks after the first pregnancy test, to rule out a false positive pregnancy test),
    9. Iron deficiency anemia defined as hemoglobin < 10 g/dL and (ferritin < 100 ng/mL or Transferrin saturation [TFS] < 20%) at screening,
    10. History of hemochromatosis or ferritin >800 g/L,
    11. Lack of highly effective contraception in female patients of child-bearing potential:
    This exclusion criterion excludes any woman or man who is not currently using or is not willing to continue to use a highly effective method of birth control (see next paragraph) or is sexually abstinent, unless she is surgically sterilized (tubal ligation and/or hysterectomy), post menopausal (amenorrhea for at least 1 year before screening) or has a vasectomized partner.
    A hormonal contraceptive drug (the “pill” or a 3-month injection), an IUD (loop) or sterilization is considered an effective contraceptive method that has been taken for at least 2 months before study entry. If these do not apply, the patient can also use an IUD and a condom (for the male partner).
    Men who are sexually active and have not been sterilized surgically must use a condom during intercourse and ensure, in addition, that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the entire clinical study. This is to prevent a pregnancy from possibly damaged sperm. Therefore, patients must not conceive a child during the clinical study and for up to 1 month after the intake of the study drug.
    12. Significant gastrointestinal disorder (including known active peptic ulcer, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, motility disorder of the intestines [symptomatic gastroparesis {treated or untreated}, ileus, severe constipation, pseudo obstruction, megacolon, or mechanical obstruction], and history of major gastrointestinal surgery),
    13. Hepatitis B (hepatitis B surface antigen [HBsAg] positivity only), hepatitis C (hepatitis C virus ribonucleic acid [HCV RNA] positivity only, patients with negative HCV RNA test can be enrolled) or other significant concurrent liver disorders (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the upper limit of the normal range),
    14. Known seropositivity to human immunodeficiency virus (HIV),
    15. Active infection or is being treated with antibiotics at screening,
    Patients who are treated with antibiotics will leave the study and may be rescreened once the infection is resolved and the treatment with antibiotics finished.
    16. Intention to change diet during the study and / or known or suspected non compliance with dietary phosphate restrictions,
    17. History of drug or alcohol abuse within 2 years before screening,
    18. Use of antacids containing aluminum or magnesium within 1 month before screening,
    19. Use of oral iron preparations within 1 month before screening,
    20. Serious medical condition, uncontrolled systemic disease, planned major surgery that would request long stay (> 1 week) in hospital or suspected life expectancy of <12 months per Investigator’s assessment,
    21. Inability to fully comprehend and/or perform study procedures (in the Investigator’s opinion),
    22. Receipt of any other investigational drug <30 days before the study or during the study,
    23. Any other medical conditions that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study.
    24. Patients taking anti-arrhythmic and anti-seizure medication,
    25. Treatment with sevelamer (as Renagel® or Renvela®) or lanthanum carbonate (Fosrenol®) at any time during the patient’s life.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in serum-phosphate levels at the end of treatment
    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 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
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state23
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 252
    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 Decision2009-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
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