European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00838097
First received: February 5, 2009
Last updated: February 27, 2014
Last verified: February 2014
  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
Chronic Kidney Disease

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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:


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
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Darbepoetin alfa
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.

  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 estimated glomerular filtration rate (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 participant 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:
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: February 27, 2014
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 April 17, 2014