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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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- 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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Arlon
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Ath
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Bonheiden
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Brugge
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Brussels
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Brussel
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Belgium
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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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Gent
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Gilly
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Huy
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Ieper
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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.