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
Sponsor study identifier
observational
321
0 countries
N/A
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 5, 2009
Actual (reported)February 6, 2009
Actual (reported)February 2013
Actual (reported)February 2013
Actual (reported)July 9, 2014
Actual (reported)Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
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).
2 years
Hemoglobin Concentration by Three Monthly Intervals
Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Baseline and Months 1 to 24
Parathyroid Hormone Level by Three Monthly Intervals
Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
Number of Participants With Non-serious Adverse Drug Reactions (ADRs)
2 years
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
Specialist Centres
MD
Amgen
321 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Nortriptyline and the Risk of Serious Adverse Events
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
August 1, 2014
Results First Posted
July 9, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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