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: June 6, 2014
Last verified: June 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:
  • Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).


Secondary Outcome Measures:
  • Hemoglobin Concentration by Three Monthly Intervals [ Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 ] [ Designated as safety issue: No ]
  • Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals [ Time Frame: Baseline and Months 1 to 24 ] [ Designated as safety issue: No ]
    Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.

  • Parathyroid Hormone Level by Three Monthly Intervals [ Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 ] [ Designated as safety issue: No ]
  • Number of Participants With Non-serious Adverse Drug Reactions (ADRs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:

    • Fatal
    • Life threatening
    • Required or prolonged in-patient hospitalization
    • A persistent or significant disability/incapacity, or
    • A congenital anomaly/birth defect.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 4, 2014
Last Updated: June 6, 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 July 28, 2014