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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391287




Registration number
NCT00391287
Ethics application status
Date submitted
20/10/2006
Date registered
23/10/2006
Date last updated
3/10/2014

Titles & IDs
Public title
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
Scientific 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
Secondary ID [1] 0 0
EPOANE4014
Secondary ID [2] 0 0
CR011587
Universal Trial Number (UTN)
Trial acronym
PRIMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pure Red-Cell Aplasia 0 0
Chronic Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA)
Timepoint [1] 0 0
Unexplained Loss of Effect (LOE) follow-up
Secondary outcome [1] 0 0
sensitivity analyses
Timepoint [1] 0 0
Unexplained Loss of Effect (LOE) follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
15334
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Central Queensland M C
Recruitment hospital [3] 0 0
- Fremantle
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Launceston
Recruitment hospital [6] 0 0
- Liverpool
Recruitment hospital [7] 0 0
- Newcastle
Recruitment hospital [8] 0 0
- Parkville
Recruitment hospital [9] 0 0
- Perth
Recruitment hospital [10] 0 0
- Randwick
Recruitment hospital [11] 0 0
- Wollongong
Recruitment hospital [12] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Central Queensland M C
Recruitment postcode(s) [3] 0 0
- Fremantle
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
- Launceston
Recruitment postcode(s) [6] 0 0
- Liverpool
Recruitment postcode(s) [7] 0 0
- Newcastle
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment postcode(s) [10] 0 0
- Randwick
Recruitment postcode(s) [11] 0 0
- Wollongong
Recruitment postcode(s) [12] 0 0
- Woodville
Recruitment outside Australia
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Belgium
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Aalst
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Belgium
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Antwerpen
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Belgium
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Arlon
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Belgium
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Assebroek
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Belgium
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Ath
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Belgium
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Bonheiden
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
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Charleroi
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Belgium
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Deinze
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Belgium
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Doornik
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Edegem
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Eeklo
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Frameries
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Genk
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Gent
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Gilly
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Huy
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Belgium
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Ieper
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La Louviere
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Leuven
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Liege
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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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Belgium
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Turnhout
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Westmalle
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Wilrijk
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Denmark
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Holstebro N/A
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Sønderborg
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Denmark
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Viborg
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Denmark
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Århus N N/A
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Helsinki
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Dillingen
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Zwickau
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Chalkida
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Edessa
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Grevena
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Ioannina
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Iraklio
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Larisa
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Piraias
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Rodos
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Serres
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Veroia
Country [240] 0 0
Ireland
State/province [240] 0 0
Cork
Country [241] 0 0
Ireland
State/province [241] 0 0
Galway
Country [242] 0 0
Netherlands
State/province [242] 0 0
'S-Hertogenbosch
Country [243] 0 0
Netherlands
State/province [243] 0 0
Apeldoorn
Country [244] 0 0
Netherlands
State/province [244] 0 0
Rotterdam
Country [245] 0 0
Netherlands
State/province [245] 0 0
Weert
Country [246] 0 0
Norway
State/province [246] 0 0
Oslo
Country [247] 0 0
Norway
State/province [247] 0 0
Trondheim N/A
Country [248] 0 0
Norway
State/province [248] 0 0
Tvnsberg
Country [249] 0 0
Poland
State/province [249] 0 0
Bialystok
Country [250] 0 0
Poland
State/province [250] 0 0
Bytom
Country [251] 0 0
Poland
State/province [251] 0 0
Chojnice
Country [252] 0 0
Poland
State/province [252] 0 0
Ciechanow
Country [253] 0 0
Poland
State/province [253] 0 0
Dzialdowo
Country [254] 0 0
Poland
State/province [254] 0 0
Gdansk-Zaspa
Country [255] 0 0
Poland
State/province [255] 0 0
Gdansk
Country [256] 0 0
Poland
State/province [256] 0 0
Koszalin
Country [257] 0 0
Poland
State/province [257] 0 0
Lodz
Country [258] 0 0
Poland
State/province [258] 0 0
Lomza N/A
Country [259] 0 0
Poland
State/province [259] 0 0
Lublin
Country [260] 0 0
Poland
State/province [260] 0 0
Olawa
Country [261] 0 0
Poland
State/province [261] 0 0
Poznan
Country [262] 0 0
Poland
State/province [262] 0 0
Proszowice
Country [263] 0 0
Poland
State/province [263] 0 0
Radomsko
Country [264] 0 0
Poland
State/province [264] 0 0
Rybnik
Country [265] 0 0
Poland
State/province [265] 0 0
Stalowa Wola N/A
Country [266] 0 0
Poland
State/province [266] 0 0
Torun
Country [267] 0 0
Poland
State/province [267] 0 0
Warszawa
Country [268] 0 0
Poland
State/province [268] 0 0
Wroclaw
Country [269] 0 0
Portugal
State/province [269] 0 0
Aveiro
Country [270] 0 0
Portugal
State/province [270] 0 0
Barcelos
Country [271] 0 0
Portugal
State/province [271] 0 0
Braga
Country [272] 0 0
Portugal
State/province [272] 0 0
Coimbra
Country [273] 0 0
Portugal
State/province [273] 0 0
Evora N/A
Country [274] 0 0
Portugal
State/province [274] 0 0
Faro
Country [275] 0 0
Portugal
State/province [275] 0 0
Leiria
Country [276] 0 0
Portugal
State/province [276] 0 0
P-1100 Lisboa N/A
Country [277] 0 0
Portugal
State/province [277] 0 0
Portalegre
Country [278] 0 0
Portugal
State/province [278] 0 0
Porto
Country [279] 0 0
Portugal
State/province [279] 0 0
S. Joao Da Madeira
Country [280] 0 0
Portugal
State/province [280] 0 0
Setubal N/A
Country [281] 0 0
Portugal
State/province [281] 0 0
Viana Do Castelo
Country [282] 0 0
Portugal
State/province [282] 0 0
Vila Nova De Gaia
Country [283] 0 0
Spain
State/province [283] 0 0
Alcorcon
Country [284] 0 0
Spain
State/province [284] 0 0
Barcelona
Country [285] 0 0
Spain
State/province [285] 0 0
Burgos
Country [286] 0 0
Spain
State/province [286] 0 0
Castellón
Country [287] 0 0
Spain
State/province [287] 0 0
Girona
Country [288] 0 0
Spain
State/province [288] 0 0
Leganés
Country [289] 0 0
Spain
State/province [289] 0 0
León
Country [290] 0 0
Spain
State/province [290] 0 0
Madrid
Country [291] 0 0
Spain
State/province [291] 0 0
Manresa
Country [292] 0 0
Spain
State/province [292] 0 0
Maranon
Country [293] 0 0
Spain
State/province [293] 0 0
Mollet Del Valles
Country [294] 0 0
Spain
State/province [294] 0 0
Oviedo
Country [295] 0 0
Spain
State/province [295] 0 0
Palma De Mallorca
Country [296] 0 0
Spain
State/province [296] 0 0
Sabadell
Country [297] 0 0
Spain
State/province [297] 0 0
Santa Cruz De Tenerife
Country [298] 0 0
Spain
State/province [298] 0 0
Santander
Country [299] 0 0
Spain
State/province [299] 0 0
Teruel
Country [300] 0 0
Spain
State/province [300] 0 0
Valencia N/A
Country [301] 0 0
Spain
State/province [301] 0 0
Valencia
Country [302] 0 0
Spain
State/province [302] 0 0
Valladolid
Country [303] 0 0
Spain
State/province [303] 0 0
Zaragoza
Country [304] 0 0
Sweden
State/province [304] 0 0
Avesta
Country [305] 0 0
Sweden
State/province [305] 0 0
Bollnäs
Country [306] 0 0
Sweden
State/province [306] 0 0
Borås
Country [307] 0 0
Sweden
State/province [307] 0 0
Eksjö
Country [308] 0 0
Sweden
State/province [308] 0 0
Eskilstuna
Country [309] 0 0
Sweden
State/province [309] 0 0
Gällivare
Country [310] 0 0
Sweden
State/province [310] 0 0
Gävle
Country [311] 0 0
Sweden
State/province [311] 0 0
Göteborg
Country [312] 0 0
Sweden
State/province [312] 0 0
Halmstad
Country [313] 0 0
Sweden
State/province [313] 0 0
Karlshamn
Country [314] 0 0
Sweden
State/province [314] 0 0
Karlskoga
Country [315] 0 0
Sweden
State/province [315] 0 0
Karlskrona
Country [316] 0 0
Sweden
State/province [316] 0 0
Köping
Country [317] 0 0
Sweden
State/province [317] 0 0
Linköping
Country [318] 0 0
Sweden
State/province [318] 0 0
Lulea
Country [319] 0 0
Sweden
State/province [319] 0 0
Malmö
Country [320] 0 0
Sweden
State/province [320] 0 0
Norrköping
Country [321] 0 0
Sweden
State/province [321] 0 0
Nyköping
Country [322] 0 0
Sweden
State/province [322] 0 0
Skellefteå
Country [323] 0 0
Sweden
State/province [323] 0 0
Skene
Country [324] 0 0
Sweden
State/province [324] 0 0
Skövde
Country [325] 0 0
Sweden
State/province [325] 0 0
Stockholm N/A
Country [326] 0 0
Sweden
State/province [326] 0 0
Stockholm
Country [327] 0 0
Sweden
State/province [327] 0 0
Sundsvall
Country [328] 0 0
Sweden
State/province [328] 0 0
Trollhättan
Country [329] 0 0
Sweden
State/province [329] 0 0
Umeå
Country [330] 0 0
Sweden
State/province [330] 0 0
Uppsala
Country [331] 0 0
Sweden
State/province [331] 0 0
Varberg N/A
Country [332] 0 0
Sweden
State/province [332] 0 0
Värnamo
Country [333] 0 0
Sweden
State/province [333] 0 0
Västervik
Country [334] 0 0
Sweden
State/province [334] 0 0
Västerås
Country [335] 0 0
Sweden
State/province [335] 0 0
Örebro
Country [336] 0 0
Sweden
State/province [336] 0 0
Örnsköldsvik N/A
Country [337] 0 0
Sweden
State/province [337] 0 0
Östersund
Country [338] 0 0
Switzerland
State/province [338] 0 0
Aarau
Country [339] 0 0
Switzerland
State/province [339] 0 0
Baden
Country [340] 0 0
Switzerland
State/province [340] 0 0
Bellinzona
Country [341] 0 0
Switzerland
State/province [341] 0 0
Chur
Country [342] 0 0
Switzerland
State/province [342] 0 0
Lausanne
Country [343] 0 0
Switzerland
State/province [343] 0 0
Nyon
Country [344] 0 0
Switzerland
State/province [344] 0 0
Schwyz
Country [345] 0 0
Switzerland
State/province [345] 0 0
Sierre
Country [346] 0 0
Switzerland
State/province [346] 0 0
Sion
Country [347] 0 0
Switzerland
State/province [347] 0 0
Wil Sg
Country [348] 0 0
Switzerland
State/province [348] 0 0
Zurich
Country [349] 0 0
United Kingdom
State/province [349] 0 0
Antrim
Country [350] 0 0
United Kingdom
State/province [350] 0 0
Basildon
Country [351] 0 0
United Kingdom
State/province [351] 0 0
Bradford
Country [352] 0 0
United Kingdom
State/province [352] 0 0
Brighton
Country [353] 0 0
United Kingdom
State/province [353] 0 0
Cambridge
Country [354] 0 0
United Kingdom
State/province [354] 0 0
Cardiff
Country [355] 0 0
United Kingdom
State/province [355] 0 0
Carshalton
Country [356] 0 0
United Kingdom
State/province [356] 0 0
Derby
Country [357] 0 0
United Kingdom
State/province [357] 0 0
Doncaster N/A
Country [358] 0 0
United Kingdom
State/province [358] 0 0
Dundee
Country [359] 0 0
United Kingdom
State/province [359] 0 0
Edinburgh
Country [360] 0 0
United Kingdom
State/province [360] 0 0
Exeter
Country [361] 0 0
United Kingdom
State/province [361] 0 0
Great Yarmouth
Country [362] 0 0
United Kingdom
State/province [362] 0 0
Inverness
Country [363] 0 0
United Kingdom
State/province [363] 0 0
Kilmarnock
Country [364] 0 0
United Kingdom
State/province [364] 0 0
Leicester
Country [365] 0 0
United Kingdom
State/province [365] 0 0
Londonderry
Country [366] 0 0
United Kingdom
State/province [366] 0 0
London
Country [367] 0 0
United Kingdom
State/province [367] 0 0
Manchester
Country [368] 0 0
United Kingdom
State/province [368] 0 0
Merseyside
Country [369] 0 0
United Kingdom
State/province [369] 0 0
Merthyr Tydfil
Country [370] 0 0
United Kingdom
State/province [370] 0 0
Norwich
Country [371] 0 0
United Kingdom
State/province [371] 0 0
Nottingham
Country [372] 0 0
United Kingdom
State/province [372] 0 0
Oxford
Country [373] 0 0
United Kingdom
State/province [373] 0 0
Plymouth
Country [374] 0 0
United Kingdom
State/province [374] 0 0
Portsmouth
Country [375] 0 0
United Kingdom
State/province [375] 0 0
Reading
Country [376] 0 0
United Kingdom
State/province [376] 0 0
Sheffield
Country [377] 0 0
United Kingdom
State/province [377] 0 0
Shrewsbury
Country [378] 0 0
United Kingdom
State/province [378] 0 0
Stevenage N/A
Country [379] 0 0
United Kingdom
State/province [379] 0 0
Suffolk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen-Cilag International NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00391287