- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391287
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure (PRIMS)
A Prospective, Immunogenicity Surveillance Registry (PRIMS) to Estimate the Incidence of Erythropoietin Antibody-Mediated Pure Red Cell Aplasia Among Subjects With Chronic Renal Failure and Subcutaneous Exposure to Recombinant Erythropoietin Products
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Adelaide, Australia
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Central Queensland M C, Australia
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Fremantle, Australia
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Hobart, Australia
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Launceston, Australia
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Liverpool, Australia
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Newcastle, Australia
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Parkville, Australia
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Perth, Australia
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Randwick, Australia
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Wollongong, Australia
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Woodville, Australia
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Aalst, Belgium
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Antwerpen, Belgium
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Arlon, Belgium
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Assebroek, Belgium
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Ath, Belgium
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Bonheiden, Belgium
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Brugge, Belgium
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Brussel, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Deinze, Belgium
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Doornik, Belgium
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Edegem, Belgium
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Eeklo, Belgium
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Frameries, Belgium
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Genk, Belgium
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Gent, Belgium
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Gilly, Belgium
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Huy, Belgium
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Ieper, Belgium
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La Louviere, Belgium
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Leuven, Belgium
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Liege, Belgium
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Liège, Belgium
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Mons, Belgium
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Namur, Belgium
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Roeselare, Belgium
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Sint-Gillis-Dendermonde, Belgium
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Sint-Niklaas, Belgium
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St-Truiden, Belgium
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Turnhout, Belgium
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Westmalle, Belgium
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Wilrijk, Belgium
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Holstebro N/A, Denmark
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Sønderborg, Denmark
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Viborg, Denmark
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Århus N N/A, Denmark
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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Aachen, Germany
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Aalen, Germany
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Altötting, Germany
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Alzey, Germany
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Annaberg-Buchholz, Germany
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Ansbach, Germany
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Arnstadt, Germany
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Aschersleben, Germany
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Augsburg, Germany
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Aurich, Germany
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Bad Bevensen, Germany
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Bad Ems, Germany
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Bad Homburg, Germany
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Bad Krozingen, Germany
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Bad König, Germany
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Bad Mergentheim, Germany
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Bad Nenndorf, Germany
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Bad Oeynhausen, Germany
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Bad Tölz, Germany
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Bassum, Germany
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Bergisch Gladbach, Germany
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Berlin, Germany
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Bernburg, Germany
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Betzdorf, Germany
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Biberach, Germany
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Bielefeld, Germany
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Bischofswerda, Germany
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Bonn, Germany
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Braunschweig, Germany
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Bremen, Germany
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Bremerhaven, Germany
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Coburg, Germany
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Cochem, Germany
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Coesfeld, Germany
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Cottbus, Germany
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Darmstadt, Germany
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Deggendorf, Germany
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Dillingen, Germany
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Dinkelsbühl, Germany
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Dormagen, Germany
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Düsseldorf, Germany
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Eberswalde, Germany
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Eisenach, Germany
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Elmshorn, Germany
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Elsenfeld, Germany
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Emmering, Germany
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Emsdetten, Germany
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Erftstadt, Germany
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Erfurt, Germany
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Erkelenz, Germany
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Essen, Germany
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Finsterwalde, Germany
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Flensburg, Germany
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Frankfurt, Germany
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Freiberg, Germany
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Freiburg, Germany
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Fürstenwalde, Germany
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Fürstenzell, Germany
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Fürth, Germany
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Gera, Germany
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Greifswald, Germany
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Göppingen, Germany
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Gütersloh, Germany
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Hagenow, Germany
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Halberstadt, Germany
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Hamburg, Germany
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Hameln, Germany
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Hannover, Germany
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Haßfurt, Germany
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Heidenau, Germany
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Heilbronn, Germany
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Helmstedt, Germany
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Herford, Germany
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Herzberg, Germany
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Hilden, Germany
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Hildesheim, Germany
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Hoyerswerda, Germany
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Hürth, Germany
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Ibbenbüren, Germany
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Immenstadt, Germany
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Ingolstadt, Germany
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Jena, Germany
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Kaiserslautern, Germany
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Kamen, Germany
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Kelheim, Germany
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Kempten, Germany
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Kerpen, Germany
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Kiel, Germany
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Kleve, Germany
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Kronach, Germany
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Kulmbach, Germany
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Köln, Germany
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Lahr, Germany
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Landshut, Germany
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Landstuhl, Germany
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Langenfeld, Germany
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Langenhagen, Germany
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Langenselbold, Germany
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Lehrte, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Lichtenfels, Germany
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Lindau, Germany
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Linnich, Germany
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Lohr, Germany
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Lutherstadt Wittenberg, Germany
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Lübeck, Germany
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Lüdenscheid, Germany
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Lüneburg, Germany
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Magdeburg, Germany
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Malente, Germany
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Mannheim, Germany
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Marburg, Germany
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Markkleeberg, Germany
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Marl, Germany
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Mayen, Germany
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Meiningen, Germany
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Moers, Germany
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Mönchengladbach, Germany
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Mühlhausen, Germany
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München, Germany
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Münster, Germany
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Neubrandenburg, Germany
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Neunkirchen, Germany
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Neuruppin, Germany
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Nürnberg, Germany
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Nürtingen, Germany
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Oberschleißheim, Germany
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Offenburg, Germany
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Olpe, Germany
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Passau, Germany
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Peine, Germany
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Pfaffenhofen, Germany
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Pforzheim, Germany
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Potsdam, Germany
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Quedlinburg, Germany
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Regensburg, Germany
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Remagen, Germany
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Rosenheim, Germany
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Rostock, Germany
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Rüsselsheim, Germany
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Saarlouis, Germany
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Sachsen, Germany
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Salzgitter, Germany
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Schwabach, Germany
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Schwedt, Germany
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Schweinfurt, Germany
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Schwerin, Germany
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Schönebeck, Germany
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Seehausen, Germany
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Seelow, Germany
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Siegen, Germany
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Sigmaringen, Germany
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Sindelfingen, Germany
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Singen, Germany
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Sinsheim, Germany
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Sonneberg, Germany
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Spremberg, Germany
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St Martin, Germany
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St Wendel, Germany
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Stade, Germany
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Straubing, Germany
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Stuttgart, Germany
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Suhl, Germany
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Tangermünde, Germany
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Traunstein, Germany
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Uelzen, Germany
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Viersen, Germany
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Villingen-Schwenningen, Germany
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Waiblingen, Germany
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Waldshut-Tiengen, Germany
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Weinheim, Germany
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Weißenburg, Germany
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Weißenfels, Germany
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Weißwasser, Germany
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Wesseling, Germany
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Weyhausen, Germany
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Wiesbaden, Germany
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Wolfenbüttel, Germany
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Worms, Germany
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Wuppertal, Germany
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Würzburg, Germany
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Zirndorf, Germany
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Zwickau, Germany
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Alexandroupolis, Greece
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Athens, Greece
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Chalkida, Greece
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Didimoteicho, Greece
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Edessa, Greece
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Grevena, Greece
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Ioannina, Greece
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Iraklio, Greece
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Larisa, Greece
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Piraias, Greece
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Rodos, Greece
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Serres, Greece
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Thessaloniki, Greece
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Thessalonikis, Greece
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Veroia, Greece
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Cork, Ireland
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Galway, Ireland
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'S-Hertogenbosch, Netherlands
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Apeldoorn, Netherlands
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Rotterdam, Netherlands
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Weert, Netherlands
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Oslo, Norway
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Trondheim N/A, Norway
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Tvnsberg, Norway
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Bialystok, Poland
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Bytom, Poland
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Chojnice, Poland
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Ciechanow, Poland
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Dzialdowo, Poland
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Gdansk, Poland
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Gdansk-Zaspa, Poland
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Koszalin, Poland
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Lodz, Poland
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Lomza N/A, Poland
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Lublin, Poland
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Olawa, Poland
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Poznan, Poland
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Proszowice, Poland
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Radomsko, Poland
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Rybnik, Poland
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Stalowa Wola N/A, Poland
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Torun, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Aveiro, Portugal
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Barcelos, Portugal
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Braga, Portugal
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Coimbra, Portugal
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Evora N/A, Portugal
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Faro, Portugal
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Leiria, Portugal
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P-1100 Lisboa N/A, Portugal
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Portalegre, Portugal
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Porto, Portugal
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S. Joao Da Madeira, Portugal
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Setubal N/A, Portugal
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Viana Do Castelo, Portugal
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Vila Nova De Gaia, Portugal
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Alcorcon, Spain
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Barcelona, Spain
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Burgos, Spain
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Castellón, Spain
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Girona, Spain
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Leganés, Spain
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León, Spain
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Madrid, Spain
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Manresa, Spain
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Maranon, Spain
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Mollet Del Valles, Spain
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Oviedo, Spain
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Palma De Mallorca, Spain
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Sabadell, Spain
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Santa Cruz De Tenerife, Spain
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Santander, Spain
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Teruel, Spain
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Valencia, Spain
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Valencia N/A, Spain
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Valladolid, Spain
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Zaragoza, Spain
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Avesta, Sweden
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Bollnäs, Sweden
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Borås, Sweden
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Eksjö, Sweden
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Eskilstuna, Sweden
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Gällivare, Sweden
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Gävle, Sweden
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Göteborg, Sweden
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Halmstad, Sweden
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Karlshamn, Sweden
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Karlskoga, Sweden
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Karlskrona, Sweden
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Köping, Sweden
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Linköping, Sweden
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Lulea, Sweden
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Malmö, Sweden
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Norrköping, Sweden
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Nyköping, Sweden
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Skellefteå, Sweden
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Skene, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Stockholm N/A, Sweden
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Sundsvall, Sweden
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Trollhättan, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Varberg N/A, Sweden
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Värnamo, Sweden
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Västervik, Sweden
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Västerås, Sweden
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Örebro, Sweden
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Örnsköldsvik N/A, Sweden
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Östersund, Sweden
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Aarau, Switzerland
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Baden, Switzerland
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Bellinzona, Switzerland
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Chur, Switzerland
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Lausanne, Switzerland
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Nyon, Switzerland
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Schwyz, Switzerland
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Sierre, Switzerland
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Sion, Switzerland
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Wil Sg, Switzerland
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Zurich, Switzerland
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Antrim, United Kingdom
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Basildon, United Kingdom
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Bradford, United Kingdom
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Brighton, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Carshalton, United Kingdom
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Derby, United Kingdom
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Doncaster N/A, United Kingdom
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Dundee, United Kingdom
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Edinburgh, United Kingdom
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Exeter, United Kingdom
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Great Yarmouth, United Kingdom
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Inverness, United Kingdom
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Kilmarnock, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Londonderry, United Kingdom
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Manchester, United Kingdom
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Merseyside, United Kingdom
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Merthyr Tydfil, United Kingdom
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Norwich, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Plymouth, United Kingdom
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Portsmouth, United Kingdom
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Reading, United Kingdom
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Sheffield, United Kingdom
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Shrewsbury, United Kingdom
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Stevenage N/A, United Kingdom
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Suffolk, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
All patients should have documented chronic renal failure (CRF) and be receiving or about to receive (within 1 month) a marketed erythropoietin product by the subcutaneous route of administration at the time of enrollment. Patients may be at any stage of CRF (Stages 1 to 5) or be receiving any treatment for CRF, including predialysis, peritoneal dialysis, or hemodialysis, but should not be receiving immunosuppressive treatment following an organ transplant.
Patients will be enrolled at sites located in the E.U. and Australia.
Description
Inclusion Criteria:
- Patients with established CRF as an indication for the treatment of anemia
- Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin (i.e., epoetin alfa [EPREX/ERYPO/GLOBUREN], epoetin beta [NEORECORMON®], or darbepoetin alfa [ARANESP®]) by the s.c. route of administration
- Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year.
Exclusion Criteria:
- Patients with a history of pure red cell aplasia or aplastic anemia
- Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
- Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
- Patients with a history of EPO antibodies prior to enrollment
- Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
- Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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erythropoietin treatment in CRF
Patients exposed to EPREX or other marketed erythropoietin products administered by the subcutaneous route of administration for the treatment of anemia of Chronic Renal Failure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA)
Time Frame: Unexplained Loss of Effect (LOE) follow-up
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estimate the incidence rate of EPO antibody-mediated PRCA with s.c.
exposure to the polysorbate 80 formulation of epoetin alfa and to compare this incidence rate to the incidence rate with s.c.
exposure to other currently marketed recombinant erythropoietin products (epoetin alfa, epoetin beta, darbepoetin alfa) with adjustment for duration of exposure.
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Unexplained Loss of Effect (LOE) follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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sensitivity analyses
Time Frame: Unexplained Loss of Effect (LOE) follow-up
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to examine, in sensitivity analyses of the incidence rates of EPO antibody-mediated Pure Red Cell Aplasia (PRCA) and their rate ratios, the impact of the patterns of mixed s.c.
exposure to multiple erythropoietin products occurring in this subject population and of varying the assumption of 1 to 12 months for latency from exposure to the onset of PRCA
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Unexplained Loss of Effect (LOE) follow-up
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR011587
- EPOANE4014 (Other Identifier: Janssen-Cilag International NV)
- 001992-001 (Other Identifier: Legacy System ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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