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    Summary
    EudraCT Number:2010-022011-19
    Sponsor's Protocol Code Number:PA-CL-05A
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-15
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2010-022011-19
    A.3Full title of the trial
    An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared with Sevelamer Carbonate Followed by a Randomised Comparison of PA21-Maintenance Dose Versus PA21-Low Dose in Dialysis Patients with Hyperphosphataemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study to investigate the safety and efficacy of PA21, a phosphate binder, in dialysis patients with hyperphosphatemia
    A.4.1Sponsor's protocol code numberPA-CL-05A
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01324128
    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 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 supportVifor (International) Inc.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor (International) Inc.
    B.5.2Functional name of contact pointMaxim Voropayev
    B.5.3 Address:
    B.5.3.1Street AddressFlugofstrasse 61
    B.5.3.2Town/ cityGlatbrugg, Zurich
    B.5.3.3Post code8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41588518223
    B.5.6E-mailmaxim.voropayev@viforpharma.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 namePA21-2
    D.3.2Product code PA21-2
    D.3.4Pharmaceutical form Chewable 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.3.9.3Other descriptive nameMixture of iron(III)-oxyhydroxide
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Renvela
    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 nameRenvela
    D.3.4Pharmaceutical form Film-coated 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 INNSEVELAMER CARBONATE
    D.3.9.1CAS number 845273-93-0
    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) 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: 3
    D.1.2 and D.1.3IMP Role
    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 namePA21-1
    D.3.2Product code PA21-1
    D.3.4Pharmaceutical form Chewable 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.3.9.3Other descriptive nameMixture of iron(III)-oxyhydroxide
    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) 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
    Control of hyperphosphataemia in patients with chronic kidney disease on dialysis
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney disease patients on dialysis with hight phosphate
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10020711
    E.1.2Term Hyperphosphataemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To Establish the superiority of PA21-maintenance dose versus PA21-low dose control in maintaining the phosphate lowering effect in haemodialysis (HD) patients after 24 weeks of PA21 treatment
    E.2.2Secondary objectives of the trial
    •Assess the long term safety and tolerability of PA21 in dialysis patients

    •Establish the non-inferiority (with possible assessment of superiority) of PA21 versus sevelamer carbonate in lowering serum phosphate in dialysis patients after 12 weeks of treatment

    •Assess Quality of Life

    •Compare safety and tolerability of PA21 versus sevelamer carbonate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects receiving maintenance HD 3 times/week with a Kt/V of ≥1.2 or peritoneal dialysis (PD) with a Kt/V of ≥1.7 within the last 3 months prior to screening. No home HD or nocturnal HD (overnight stay at site) will be allowed.

    2.Subjects with a history of hyperphosphataemia and receiving stable doses of a phosphate binder(s) for at least 1 month prior to screening. Subjects may be on stable doses of 1 or 2 phosphate binders.

    3.Male and female adult subjects (aged ≥18 years at time of consent).

    4.Subjects with serum phosphate levels ≥1.94 mmol/L (≥6.0 mg/dL) at any time during the washout period.

    5.Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments, in the Investigator’s opinion.

    6.Subjects (or their legally acceptable representative) who have provided the appropriate written informed consent. Subjects must provide written informed consent before any study-specific procedures are performed including screening procedures.
    E.4Principal exclusion criteria
    1.Subjects with intact parathyroid hormone (iPTH) levels >800 ng/L (>800 pg/ml or 88 pmol/L) at screening. Subjects with iPTH >600 ng/L (>600 pg/ml or 66 pmol/L) at screening must be considered stable in the Investigator’s opinion.

    2.Subjects with planned or expected parathyroidectomy within the next 12 months, in the Investigator’s opinion.

    3.Subjects with anticipated need for major surgery during the study that may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator’s opinion.

    4.Subjects with history (within 3 years of screening) of:
    Major gastrointestinal surgery likely to influence the outcome of treatment with phosphate binders
    Significant gastrointestinal or hepatic disorders

    5.Subjects currently with, in the Investigator’s opinion:
    Unstable angina
    Unstable hypertension
    Uncontrolled diabetes
    Estimated life expectancy of less than 12 months
    Anticipated renal transplantation during study participation

    6.Subjects with known seropositivity to human immunodeficiency virus.

    7.Subjects with active hepatitis (hepatitis B or C surface antigen positive).

    8.Subjects with significant medical conditions which, in the Investigator’s opinion, may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide informed consent or comply with study procedures.

    9.Subjects with:
    − A history of haemochromatosis or other iron accumulation disturbances that might lead to iron overload
    − Serum ferritin >2,000 mcg/L (4,494 pmol/L) at screening.

    10.Subjects on PD with a history of peritonitis in the last 3 months or ≥3 episodes in the last 12 months.

    11.Subjects on non-calcium based phosphate binders with hypercalcaemia (total serum calcium >2.60 mmol/L or >10.50 mg/dL) at screening.

    12.Subjects with hypocalcaemia (total serum calcium <1.9 mmol/L or <7.6 mg/dL) at screening.

    13.Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at screening.

    14.Subjects taking any prohibited medications (see Section 7.7, Prohibited Therapy and Concomitant Treatment, page 57).

    15.Subjects taking more than 2 phosphate binders concomitantly prior to screening or subjects who are phosphate binder naïve prior to screening.

    16.Subjects with a history of drug or alcohol abuse within 2 years before screening.

    17.Subjects currently enrolled in or who have completed any other investigational device or drug study <30 days prior to screening, or subjects receiving other investigational agent(s).

    18.Subjects who are pregnant (e.g., positive human chorionic gonadotropin test), breast feeding, or, if of child-bearing potential, are not using adequate contraceptive precautions. Subjects must agree to use adequate contraception during the study and for 1 month after the last dose of the study medication.
    Adequate methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non child-bearing potential includes being surgically sterilised at least 6 months prior to the study or post menopausal, defined as amenorrhea for at least 12 months.

    19.Subjects with a known sensitivity to any of the study products to be administered during dosing.

    20.Subjects previously randomised to treatment in this or any other PA21 study.

    21.Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy:
    •Change from Week 24, D1 in serum phosphate levels at Week 27, D1 – a superiority comparison between the PA21 maintenance dose group and the PA21 low dose control group (fixed dose of 1.25 g/day) (full analysis set (FAS)) (D1 refers to the first dialysis session of the week).

    Primary Safety:
    •Adverse events (AEs) profile and routine biochemical/haematological laboratory tests.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy - Week 27
    Primary Safety - End of Study
    E.5.2Secondary end point(s)
    •Establish the non-inferiority (with possible assessment of superiority) of PA21 versus sevelamer carbonate in lowering serum phosphate in dialysis patients after 12 weeks of treatment
    •Assess Quality of Life
    •Compare safety and tolerability of PA21 versus sevelamer carbonate
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    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 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 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 Yes
    E.8.2.3.1Comparator description
    low dose PA21
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Croatia
    Czech Republic
    Germany
    Latvia
    Lithuania
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Sweden
    Switzerland
    Ukraine
    United Kingdom
    United States
    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
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial 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: 564
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 376
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 315
    F.4.2.2In the whole clinical trial 940
    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 Decision2011-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-09
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