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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [1] 0 0
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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Belgium
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Genk
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Gent
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Belgium
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Gilly
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Belgium
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Huy
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Belgium
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Ieper
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Belgium
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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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Sint-Niklaas
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St-Truiden
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Belgium
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Turnhout
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Belgium
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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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Denmark
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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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Tampere
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Turku
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Dillingen
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Dormagen
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Jena
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Langenhagen
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Lindau
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Linnich
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Marl
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Waiblingen
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Waldshut-Tiengen
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Worms
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Wuppertal
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Zirndorf
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Zwickau
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Athens
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Chalkida
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Didimoteicho
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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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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391287
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00391287