Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure

NCT00391287 | Completed

• 3 other identifiers: CR011587EPOANE4014001992-001
• Study Type: observational
• Target: 15,334
• Locations: 15 countries
• Sites: 387

Brief Summary

The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA; aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving subcutaneous (s.c.) epoetin alfa (polysorbate 80 formulation) for the treatment of anemia associated with chronic renal failure (CRF), 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 of duration for which the drug is given to the patient. The study will also examine the impact of the pattern of using mixed s.c. exposure to multiple erythropoietin products occurring in this patients, and the impact of the time from which the treatment is started to the onset of PRCA.

Conditions

Pure Red-Cell Aplasia; Chronic Kidney Failure

Keywords

Red-Cell Aplasia due to Chronic Kidney Failure; Aplastic Anemia; Recombinant Erythropoietin; Surveillance Registry; Registries

Outcome Measures

Primary Outcomes (1)

• estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA)

  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.

  Unexplained Loss of Effect (LOE) follow-up

Secondary Outcomes (1)

• sensitivity analyses

  Unexplained Loss of Effect (LOE) follow-up

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen-Cilag International NV: collaborator

Study Sites (387)

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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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Antwerp, 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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Bruges, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Deinze, 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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Ghent, Belgium

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Gilly, Belgium

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Huy, Belgium

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Ieper, Belgium

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La Louvière, Belgium

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Leuven, 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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Tournai, Belgium

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Turnhout, Belgium

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Westmalle, Belgium

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Wilrijk, Belgium

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Århus N N/A, Denmark

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Holstebro, Denmark

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Sønderborg, Denmark

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Viborg, 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 König, Germany

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Bad Krozingen, 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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Cologne, 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 im Breisgau, 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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Göppingen, Germany

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Greifswald, 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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Hamelin, Germany

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Hanover, 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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Ibbenbueren, Germany

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Immenstadt im Allgäu, 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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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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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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Nuremberg, 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 am Main, Germany

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Saarlouis, Germany

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Sachsen, Germany

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Saint Martin, Germany

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Saint Wendel, Germany

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Salzgitter, Germany

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Schönebeck, 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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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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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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Wittenberg, 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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Alexandroupoli, Greece

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Athens, Greece

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Chalcis, Greece

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Didimoteicho, Greece

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Edessa, Greece

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Grevená, Greece

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Heraklion, Greece

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Ioannina, Greece

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Larissa, Greece

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Piraias, Greece

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Rhodes, Greece

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Serres, Greece

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Thessaloniki, Greece

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Thessalonikis, Greece

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Véroia, 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, 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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Ciechanów, Poland

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Działdowo, 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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Lublin, Poland

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Oława, 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, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Łomża, 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, 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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Setúbal, Portugal

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Viana do Castelo, Portugal

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Vila Nova de Gaia, Portugal

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Alcorcón, Spain

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Barcelona, Spain

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Burgos, Spain

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Castellon, 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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Marañón, Spain

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Mollet del Vallès, 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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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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Gothenburg, 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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Luleå, Sweden

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Malmo, Sweden

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Norrköping, Sweden

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Nyköping, Sweden

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Örebro, Sweden

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Örnsköldsvik, Sweden

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Östersund, 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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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, Sweden

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Värnamo, Sweden

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Västerås, Sweden

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Västervik, 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, 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, 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, United Kingdom

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Suffolk, United Kingdom

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Related Links

• 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

MeSH Terms

Conditions

Red-Cell Aplasia, Pure; Kidney Failure, Chronic; Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

CH (11); BE (31); GB (31); PT (14); ES (20); GR (15); AU (12); SE (33); IE (2); DK (4); NO (3); NL (4); FI (3); DE (184); PL (20)