EU Registry in Paediatric CDK Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
Information source: Amgen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: OBSERVATIONAL - NO INTERVENTON (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Overall contact:
Amgen Call Center, Phone: 866-572-6436
Summary
This European study observes paediatric patients with Chronic Kidney Disease using
Darbepoeting Alfa to assess the drugs long term safety and profile the patterns of its use
within this population.
Clinical Details
Official title: A Prospective Registry Study Observing the Safety and Patterns of Use of Darbepoetin Alfa in EU Paediatric Chronic Kidney Disease Patients Receiving or Not Receiving Dialysis
Study design: Other, Prospective
Primary outcome: To assess the long-term safety of darbepoetin alfa therapy in paediatric subjects with chronic kidney disease receiving or not receiving diaslysis, as determined by the evaluation of incidence rates of SAEs, SADRs and EMIs
Secondary outcome: To assess the usage pattern of darbepoetin alfa in the Chronic Kidney Disease paediatric patient population, haemoglobin and selected related laboratory values over time, and non serious adverse drug reactions
Eligibility
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Anaemia attributed to Chronic Kidney Disease (CKD)
- Sixteen years of age or under
- Documented CKD as demonstrated by eGFR <60 mL/min/1. 73m² (Schwartz equation) for ≥3
months if not on dialysis, or: Receiving dialysis
- Treatment with darbepoetin alfa
- Documented informed consent by a parent or authorised individual, if required, and
assent by the patient if appropriate
Exclusion Criteria:
- Active malignancy or current chemotherapy or radiation therapy
- Investigator unlikely to be able to obtain adequate follow-up information, or subject
will not be available for follow-up assessment
- Currently enrolled in or has not yet completed at least 30 days since ending other
investigational device or drug study; subject receiving other investigational agents
Locations and Contacts
Amgen Call Center, Phone: 866-572-6436
Research Site, Innsbruck, Austria; Recruiting
Research Site, Wien, Austria; Recruiting
Research Site, Praha 5, Czech Republic; Recruiting
Research Site, Helsinki, Finland; Recruiting
Research Site, Vandoeuvre les Nancy, France; Recruiting
Research Site, Paris, France; Recruiting
Research Site, Marseille, France; Recruiting
Research Site, Rostock, Germany; Recruiting
Research Site, Heidelberg, Germany; Recruiting
Research Site, Hannover, Germany; Recruiting
Research Site, Marburg, Germany; Recruiting
Research Site, Köln, Germany; Recruiting
Research Site, Essen, Germany; Recruiting
Research Site, Budapest, Hungary; Recruiting
Research Site, Szeged, Hungary; Recruiting
Research Site, Padova, Italy; Recruiting
Research Site, Torino, Italy; Recruiting
Research Site, Roma, Italy; Recruiting
Research Site, Genova, Italy; Recruiting
Research Site, Palermo, Italy; Recruiting
Research Site, Napoli, Italy; Recruiting
Research Site, Gdańsk, Poland; Recruiting
Research Site, Szczecin, Poland; Recruiting
Research Site, Krakow, Poland; Recruiting
Research Site, Porto, Portugal; Recruiting
Research Site, Lisboa, Portugal; Recruiting
Research Site, Barcelona, Spain; Recruiting
Research Site, Madrid, Spain; Recruiting
Research Site, Lund, Sweden; Recruiting
Research Site, Glasgow, United Kingdom; Recruiting
Additional Information
AmgenTrials clinical trials website
Starting date: February 2008
Ending date: April 2013
Last updated: October 15, 2009
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