EU Registry in Paediatric CKD Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00838097

Purpose

This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.

Condition	Intervention
Chronic Kidney Disease	Other: OBSERVATIONAL - NO INTERVENTON

Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

To assess the long-term safety of darbepoetin alfa therapy in paediatric subjects with chronic kidney disease receiving or not receiving dialysis, as determined by the evaluation of incidence rates of SAEs, SADRs and EMIs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	320
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
OTHER	Other: OBSERVATIONAL - NO INTERVENTON OBSERVATIONAL - NO INTERVENTION

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Specialist Centres

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838097

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00838097 History of Changes
Other Study ID Numbers:	20070211
Study First Received:	February 5, 2009
Last Updated:	September 29, 2011
Health Authority:	Czech Republic: Statni ustav pro kontrolu leciv; EU: CHMP; Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Amgen:

CKD
Paediatric
Darbepoetin Alfa

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012