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AzTrials

Pure Red-Cell AplasiaPRIMSNCT00391287

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

An observational study of Pure Red-Cell Aplasia and Chronic Kidney Failure, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 387 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pure Red-Cell Aplasia, Chronic Kidney Failure
Type of treatment
Injection or infusion
How many people
15,334 participants
Where
387 sitesin 15 countries
Study dates
Jun 2006to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

387 sites in 15 countries.

387 sites in 15 countries

Germany184 sites

  • Study site

    Aachen

  • Study site

    Aalen

  • Study site

    Altötting

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    Alzey

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    Annaberg-Buchholz

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    Ansbach

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    Arnstadt

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    Aschersleben

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    Augsburg

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    Aurich

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    Bad Bevensen

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    Bad Ems

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    Bad Homburg

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    Bad König

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    Bad Krozingen

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    Bad Mergentheim

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    Bad Nenndorf

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    Bad Oeynhausen

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    Bad Tölz

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    Bassum

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    Bergisch Gladbach

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    Berlin

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    Bernburg

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    Betzdorf

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    Biberach

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    Bielefeld

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    Bischofswerda

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    Bonn

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    Braunschweig

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    Bremen

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    Bremerhaven

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    Coburg

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    Cochem

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    Coesfeld

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    Cologne

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    Cottbus

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    Darmstadt

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    Deggendorf

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    Dillingen

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    Dinkelsbühl

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    Dormagen

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    Düsseldorf

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    Eberswalde

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    Eisenach

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    Elmshorn

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    Elsenfeld

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    Emmering

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    Emsdetten

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    Erftstadt

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    Erfurt

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    Erkelenz

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    Essen

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    Finsterwalde

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    Flensburg

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    Frankfurt

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    Freiberg

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    Freiburg im Breisgau

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    Fürstenwalde

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    Fürstenzell

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    Fürth

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    Gera

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    Göppingen

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    Greifswald

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    Gütersloh

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    Hagenow

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    Halberstadt

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    Hamburg

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    Hamelin

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    Hanover

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    Haßfurt

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    Heidenau

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    Heilbronn

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    Helmstedt

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    Herford

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    Herzberg

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    Hilden

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    Hildesheim

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    Hoyerswerda

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    Hürth

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    Ibbenbueren

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    Immenstadt im Allgäu

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    Ingolstadt

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    Jena

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    Kaiserslautern

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    Kamen

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    Kelheim

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    Kempten

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    Kerpen

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    Kiel

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    Kleve

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    Kronach

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    Kulmbach

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    Lahr

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    Landshut

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    Landstuhl

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    Langenfeld

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    Langenhagen

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    Langenselbold

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    Lehrte

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    Leipzig

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    Leverkusen

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    Lichtenfels

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    Lindau

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    Linnich

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    Lohr

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    Lübeck

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    Lüdenscheid

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    Lüneburg

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    Magdeburg

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    Malente

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    Mannheim

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    Marburg

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    Markkleeberg

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    Marl

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    Mayen

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    Meiningen

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    Moers

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    Mönchengladbach

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    Mühlhausen

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    München

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    Münster

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    Neubrandenburg

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    Neunkirchen

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    Neuruppin

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    Nuremberg

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    Nürtingen

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    Oberschleißheim

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    Offenburg

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    Olpe

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    Passau

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    Peine

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    Pfaffenhofen

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    Pforzheim

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    Potsdam

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    Quedlinburg

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    Regensburg

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    Remagen

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    Rosenheim

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    Rostock

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    Rüsselsheim am Main

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    Saarlouis

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    Sachsen

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    Saint Martin

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    Saint Wendel

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    Salzgitter

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    Schönebeck

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    Schwabach

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    Schwedt

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    Schweinfurt

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    Schwerin

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    Seehausen

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    Seelow

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    Siegen

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    Sigmaringen

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    Sindelfingen

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    Singen

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    Spremberg

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    Stade

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    Straubing

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    Stuttgart

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    Suhl

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    Tangermünde

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    Traunstein

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    Uelzen

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    Viersen

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    Villingen-Schwenningen

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    Waiblingen

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    Waldshut-Tiengen

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    Weinheim

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    Wesseling

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    Worms

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    Wuppertal

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    Würzburg

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    Zirndorf

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    Zwickau

Other trials in Germany

Sweden33 sites

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    Avesta

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    Bollnäs

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    Borås

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    Eksjö

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    Eskilstuna

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    Gällivare

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    Gävle

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    Halmstad

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    Karlshamn

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    Karlskoga

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    Köping

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    Linköping

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    Luleå

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    Malmö

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    Norrköping

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    Örebro

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    Skene

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    Skövde

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    Stockholm

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    Sundsvall

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    Trollhättan

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    Umeå

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    Uppsala

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    Varberg

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    Värnamo

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    Västerås

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    Västervik

Other trials in Sweden

Belgium31 sites

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    Aalst

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    Antwerp

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    Arlon

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    Assebroek

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    Ath

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    Bonheiden

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    Bruges

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    Brussels

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    Charleroi

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    Deinze

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    Edegem

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    Eeklo

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    Frameries

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    Genk

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    Ghent

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    Gilly

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    Huy

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    Ieper

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    La Louvière

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    Leuven

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    Liège

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    Mons

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    Namur

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    Roeselare

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    Sint-Gillis-Dendermonde

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    Sint-Niklaas

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    St-Truiden

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    Tournai

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    Turnhout

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    Westmalle

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    Wilrijk

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United Kingdom31 sites

  • Study site

    Antrim

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    Basildon

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    Bradford

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    Brighton

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    Dundee

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    Edinburgh

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    Exeter

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    Great Yarmouth

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    Inverness

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    Merthyr Tydfil

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    Oxford

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    Portsmouth

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    Reading

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    Sheffield

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    Shrewsbury

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    Stevenage

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    Suffolk

Other trials in United Kingdom

Poland20 sites

  • Study site

    Bialystok

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    Bytom

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    Chojnice

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    Ciechanów

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    Działdowo

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    Gdansk

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    Gdansk-Zaspa

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    Koszalin

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    Lodz

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    Łomża

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    Lublin

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    Oława

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    Poznan

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    Proszowice

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    Radomsko

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    Rybnik

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    Stalowa Wola

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    Torun

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    Warsaw

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    Wroclaw

Other trials in Poland

Spain20 sites

  • Study site

    Alcorcón

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    Barcelona

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    Burgos

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    Castellon

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    Girona

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    Leganés

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    León

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    Madrid

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    Manresa

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    Marañón

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    Mollet del Vallès

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    Oviedo

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    Palma de Mallorca

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    Sabadell

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    Santa Cruz de Tenerife

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    Santander

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    Teruel

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    Valencia

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    Valladolid

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    Zaragoza

Other trials in Spain

Greece15 sites

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    Alexandroupoli

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    Athens

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    Chalcis

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    Didimoteicho

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    Edessa

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    Grevená

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    Heraklion

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    Ioannina

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    Larissa

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    Piraias

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    Rhodes

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    Serres

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    Thessaloniki

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    Thessalonikis

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    Véroia

Other trials in Greece

Portugal14 sites

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    Aveiro

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    Barcelos

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    Braga

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    Coimbra

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    Evora

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    Faro

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    Leiria

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    P-1100 Lisboa N/A

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    Portalegre

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    Porto

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    S. Joao Da Madeira

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    Setúbal

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    Viana do Castelo

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    Vila Nova de Gaia

Other trials in Portugal

Australia12 sites

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    Adelaide

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    Central Queensland M C

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    Fremantle

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    Hobart

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    Launceston

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    Parkville

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    Perth

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    Randwick

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    Wollongong

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    Woodville

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Switzerland11 sites

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    Aarau

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    Baden

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    Bellinzona

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    Chur

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    Lausanne

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    Nyon

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    Schwyz

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    Sierre

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    Sion

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    Wil

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    Zurich

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Denmark4 sites

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    Århus N N/A

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    Holstebro

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    Sønderborg

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    Viborg

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Netherlands4 sites

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    's-Hertogenbosch

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    Apeldoorn

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    Rotterdam

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    Weert

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Finland3 sites

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    Helsinki

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    Tampere

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    Turku

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Norway3 sites

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    Oslo

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    Tvnsberg

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Ireland2 sites

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    Cork

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    Galway

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About this study

Official title: 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

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.

Read the detailed description

In 1998, prompted by concern that human serum albumin (HAS- the stabilizer in the epoetin alfa formulation) could theoretically transmit Creutzfeldt-Jakob disease and bovine spongiform encephalopathy, an alternative epoetin alfa formulation using polysorbate 80 as a stabilizer was introduced. The polysorbate 80 epoetin alfa formulation became available in a variety of product presentations (i.e., single-use vials and prefilled syringes with both coated and uncoated stoppers) to provide for prescribing flexibility, patient convenience, and choice of route of administration. Soon after the introduction of the polysorbate 80 epoetin alfa formulation in prefilled syringes, an increasing number of cases of EPO antibody-mediated pure red cell aplasia (PRCA) were reported in patients with chronic renal failure (CRF) exposed to epoetin alfa by the s.c. route. This led to contraindication of the s.c. route for epoetin alfa in the European Union (E.U.) and Switzerland in December 2002. It was subsequently shown that the increased risk for PRCA was associated with one specific polysorbate 80 epoetin alfa presentation - prefilled syringes with uncoated rubber stoppers. It appeared that uncoated rubber stoppers, when exposed to polysorbate 80, released organic compounds (leachates) into the epoetin alfa formulation, and that these leachates were the most probable product-specific cause for the increase in EPO antibody-mediated PRCA. A worldwide recall of the polysorbate 80 epoetin formulation in prefilled syringes with uncoated stoppers was completed in March 2004. FluroTec-coated stoppers are now used in all prefilled syringes containing the polysorbate 80 epoetin alfa formulation, to prevent leachates from entering the formulation. Following these actions, the incidence rate of EPO antibody-mediated PRCA in CRF patients receiving s.c. epoetin alfa fell to a level similar to that for the HSA-containing epoetin formulation, which has a long-standing and well-characterized safety profile. As of 30 November 2005, s.c. exposure in CRF patients to the polysorbate 80 epoetin alfa formulation in prefilled syringes with coated stoppers was 71,880 patient-years, with 4 cases of EPO antibody-mediated PRCA reported. In 2006, E.U. Health Authorities reauthorized s.c. epoetin alfa use in CRF patients for whom intravenous access is not readily available. As part of the reauthorization, the sponsor agreed to conduct this registry in order to demonstrate that the polysorbate 80 epoetin alfa formulation using a coated stopper has an acceptable immunogenic safety profile and to define the incidence of EPO antibody-mediated PRCA associated with recombinant erythropoietin use among patients with anemia associated with CRF. This is a multicenter, multinational, immunogenicity surveillance registry using a prospective cohort design (patients identified by a common characteristic), with enrollment of parallel groups that are exposed to the polysorbate 80 formulation of epeotin alfa or other marketed erythropoietin products administered by the s.c. route of administration for the treatment of anemia associated with CRF. The registry is designed to address the following question: Is the current rate of PRCA with the s.c. polysorbate 80 epoetin alfa formulation using coated stoppers similar to the current rate with other marketed erythropoietin products administered by the s.c. route, adjusted for duration of exposure? Each patient will be observed for development of PRCA for up to 3 years. Information on exposure to erythropoietin products, stage of CRF, treatment modality for CRF, erythropoietin handling and storage information, and most recent hemoglobin level will be collected quarterly. Cases of unexplained loss or lack of effect (LOE) with an administered erythropoietin product, including cases of suspected PRCA, will be reported to the sponsor as serious adverse events. Cases of EPO antibody-mediated PRCA will be determined by the clinical presence of suspected PRCA, an unexplained LOE with administered erythropoietin product, and the presence of EPO antibody. An Independent Case Adjudication Committee will review blinded case data for patients with unexplained LOE and identify cases of EPO antibody-mediated PRCA. A separate Independent Safety Advisory Committee will be responsible for periodically reviewing unblinded patient data and summary data and will make recommendations related to the incidence rate of PRCA associated with s.c. epoetin alfa use. The sponsor will actively monitor registry enrollment and erythropoietin brand usage to ensure that the registry accrues 20,000 person-years of s.c. exposure to epoetin alfa and 20,000 person-years of s.c. exposure to all other erythropoietin products combined. If it appears that one registry arm will meet this accrual goal before the other, the sponsor may elect to selectively close those investigational sites with predominant use of the erythropoietin product(s) in the arm approaching full accrual. The registry will provide no inducement to change therapy and will be non-interventional.

Keywords
Red-Cell Aplasia due to Chronic Kidney Failure, Aplastic Anemia, Recombinant Erythropoietin, Surveillance Registry, Registries
Medical subject headings
Red-Cell Aplasia, Pure, Kidney Failure, Chronic, Anemia, Aplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00391287
Study groupRoleWhat they receive
erythropoietin treatment in CRFPatients exposed to EPREX or other marketed erythropoietin products administered by the subcutaneous route of administration for the treatment of anemia of Chronic Renal Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Unexplained Loss of Effect (LOE) follow-up

Secondary outcomes (1)

  1. sensitivity analyses

    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

    Measured: Unexplained Loss of Effect (LOE) follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391287
Sponsor's protocol ID
CR011587
Other IDs
EPOANE4014, 001992-001
Acronym
PRIMS
Status last verified
Oct 2014
First submitted
20 Oct 2006
Last updated
3 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pure Red-Cell Aplasia and Chronic Kidney Failure, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 387 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 387 sites in Germany, Sweden, Belgium, United Kingdom, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA) (time frame: Unexplained Loss of Effect (LOE) follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.

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