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EU Registry in Paediatric CKD Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00838097
First received: February 5, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  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:

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: 321
Study Start Date: February 2008
Estimated Study Completion Date: May 2013
Primary Completion Date: March 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: Amgen
ClinicalTrials.gov Identifier: NCT00838097     History of Changes
Other Study ID Numbers: 20070211
Study First Received: February 5, 2009
Last Updated: April 1, 2013
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
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013